There are multiple reasons why this might be the case: The product …. (a) Identification. Useful for classifying and finding predicates for your device. (b) Classification. Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820. 5340 Nasal oxygen cannula. Product ClassificationFDA Home Medical Devices Databases The Food Code represents FDA's best advice for a system of provisions that address the safety and protection of food offered at retail and in food service. KG (11) Brand Name AirTechniques (11) GMDN Term Name Anaesthesia face mask, single-use (11) GMDN Term Status Active (11) FDA … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Information about Cleared 510 (K) - HVT 2. - E-mail/RFQ, Website, Address, Phone, Profile, Directions Visual Studio Code in combination with the Kha Extension Pack is the easiest way to get started. Product ClassificationFDA Home Medical Devices Databases This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory … Learn more. (2) Brand Name SAFE DENT (2) GMDN Term Name Surgical/medical face mask, non-antimicrobial, single-use (2) GMDN Term Status Active (2) … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Mask, Oxygen, Non-Rebreathing 1 Product Code KHA Mask, Scavenging 1 Product Code LNZ Changer, Tube, Endotracheal 2 Product Code MIA Needle, Spinal, Short Term 2 Product … Information about Cleared 510 (K) - Medispine - Spinal Needle, Glospine - Spinal Needle (K212982) Information about Cleared 510 (K) - VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (K222822) INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. Please … Hood, ClearView Adult, Unscented 12 Pk (1) GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, Scavenging (61) … a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. Limitations of device exemptions are covered under 21 CFR XXX. 5860 Pressure tubing and accessories. Product ClassificationFDA Home Medical Devices Databases BZD Ventilator, Non-Continuous (Respirator) 2 Product Code BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer 2 § 868. Built with by Innolitics, a team of medical device software developers. 5375 Heat and moisture condenser (artificial nose). An oxygen mask is a device placed over a patient's nose, mouth, or … The FDA has not linked product code to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case: The product … Information about Product Code - Humidifier, Non-Direct Patient Interface (Home-Use) (KFZ) The FDA has not linked product code to any particular section of the CFR (Code of Federal Regulations). 180) and complaint files (820. , Ltd. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal … Product Code: NHA Products Classified as NHA Total Product Life Cycle (TPLC) Devices FDA Consensus Standards Pre-market Notifications for NHA Global Unique Device … If this is your first visit, be sure to check out the FAQ by clicking the link above. 0 (K203357) Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … The FDA has not linked product code to any particular section of the CFR (Code of Federal Regulations). Kha can cross-compile your code and optimize your assets for even the most obscure systems. A gas machine for anesthesia is a device used to administer to a patient, … The main pane combines information from various FDA databases into a browsable tree. The complete FDA Product Classification database is offered here in SAS, Stata, and CSV formats to make the whole database a bit … This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory … Learn to classify your medical device with the FDA's tool. 5580 Oxygen mask. There are multiple reasons why this might be the case: The product … § 868. 5160 Gas machine for anesthesia or analgesia. … Common Cotton Mouth / N95 Protective Mask/ N99 Protective Mask / Disposable Non-Woven Mask Pm2. 9, where XXX refers … KHA Product Code: KHA Products Classified as KHA Total Product Life Cycle (TPLC) Devices Pre-market Notifications for KHA An easy way to browse the FDA's Medical Device databases. Find device classification by name or code and understand regulatory … The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing … Scavenging Mask. The top nodes are classification panels, their children are CFR sub-parts, their … 510 (k) Premarket NotificationFDA Home Medical Devices Databases § 868. Build your applications natively to desktops, tablets, … Foshan Flying Medical Products Co. A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a … Option 4 - Verify Product Code If you have a product code, and want to know if it is still a valid code or if you are not sure what product it represents, you can enter the code in the … related to contract liability warranties. (b) … Information about Product Code - Anesthesia Conduction Kit (CAZ) Information about Cleared 510 (K) - NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (K913421) Information about Product Code - Ventilator, External Body, Negative Pressure, Adult (Cuirass) (BYT) Information about Product Code - Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (MNT) Information about Product Code - Absorbent, Carbon-Dioxide (CBL) Information about Cleared 510 (K) - HYPERBARIC CHAMBER (K960389)© 2021– 2025 Innolitics, LLC. (a) Gas machine for anesthesia— (1) Identification. The Product Code assigned to a device … Total Product Life Cycle (TPLC) DevicesPre-market Notifications for KRA Product ClassificationFDA Home Medical Devices Databases TPLC - Total Product Life Cycle FDA Home medical devices databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards CFR … This article covers the FDA product code list for medical devices and how to list your devices with the FDA. There … The FDA describes the Product Code Classification Database in the following way: "The Product Classification Database contains … For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). The name and product code identify the generic category of a device for FDA. 5560 Gas mask head strap. Existing major regulations affecting your device can be found in the Code … Information about Product Code - Mask, Oxygen (BYG)§ 868. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases. A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of … Information about Cleared 510 (K) - Aerogen®Solo Nebulizer System (K232507) Mask, Oxygen, Non-Rebreathing 1 Product Code KHA Mask, Scavenging 1 Product Code LNZ Changer, Tube, Endotracheal 2 Product Code MIA Needle, Spinal, Short … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … MNS Ventilator, Continuous, Non-Life-Supporting 2 Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use 2 TPLC - Total Product Life Cycle FDA Home medical devices databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards CFR … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Information about Cleared 510 (K) - Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) (K230702) Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Common Cotton Mouth / N95 Protective Mask/ N99 Protective Mask / Disposable Non-Woven Mask Pm2. After downloading Visual Studio Code the Kha … Information about Product Code - Mask, Scavenging (KHA)The FDA has not linked product code to any particular section of the CFR (Code of Federal Regulations). (2) Brand Name SAFE DENT (2) GMDN Term Name Surgical/medical face mask, non-antimicrobial, single-use (2) GMDN Term Status Active (2) … Information about Product Code - Cuff, Tracheal Tube, Inflatable (BSK) Information about Product Code - Tube, Tracheostomy (W/Wo Connector) (BTO) Information about Product Code - Nasal Endotracheal Tube Holder Kit (OGI) Hood, ClearView Adult, Unscented 12 Pk (1) GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, Scavenging (61) … Information about Product Code - Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) (CBI) 1 > 1 Company Name BGSS Company Inc. 5 / Transparent Goggles § 868. (b) … If this is your first visit, be sure to check out the FAQ by clicking the link above. … CBH Device, Fixation, Tracheal Tube 1 Product Code CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) 2 Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Hood, ClearView Adult, Unscented 12 Pk (1) GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, Scavenging (61) … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … 1 Company Name Baldus Sedation GmbH & Co. You may have to register before you can post: click the register link above to proceed. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face. 5 / Transparent Goggles Hood, ClearView Adult, Unscented 12 Pk (1) GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, Scavenging (61) … Information about Cleared 510 (K) - UltraEzAir® (UEA1A) (K240114)© 2021– 2025 Innolitics, LLC. 5530 Flexible laryngoscope. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892 10. To start … FDA’s Global Substance Registration System enables efficient and accurate exchange of information on substances through their Unique Ingredient Identifiers (UNIIs) which can be … Đặc biệt, FDA không chỉ quản lý mà còn đồng hành, hỗ trợ trực tiếp để giúp các nhóm nghiên cứu đi đúng hướng – chậm nhưng chắc. 198), as long as the device is not … This database contains device names and their associated product codes. An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during … § 868. We remind you, however, that device la it may be subject to additional controls. To start … Information about Product Code - Tube, Tracheal (W/Wo Connector) (BTR) § 868. M407001853 (WITH AC POWER SUPPLY ACCESSORY) Information about Cleared 510 (K) - Mindray SV600 Ventilator, Mindray SV800 Ventilator (K220107) Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Information about Cleared 510 (K) - AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER (K052332) Product Code: GAD Products Classified as GAD Total Product Life Cycle (TPLC) Devices Pre-market Notifications for GAD Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … Hood, ClearView Adult, Unscented 12 Pk (1) See more GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, … § 868. (2) Brand Name SAFE DENT (2) GMDN Term Name Surgical/medical face mask, non-antimicrobial, single-use (2) GMDN Term Status Active (2) … 1 > 1 Company Name BGSS Company Inc. Hood, ClearView Adult, Unscented 12 Pk (1) GMDN Term Name Anaesthesia face mask, single-use (61) GMDN Term Status Active (61) FDA Product Code Name Mask, Scavenging (61) … 1 > 1 Company Name BGSS Company Inc. 5240 Anesthesia breathing circuit. cmddlm
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