Home GUDID 30606959024602 AF541
Primary DI 30606959024602
Brand AF541
Company Respironics, Inc.
Model 00
Catalog number 1121074
Device description AF541 SE WITH FOUR-POINT HEADGEAR, SMALL
Published 2016-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name CBK VENTILATOR, CONTINUOUS, FACILITY USE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CBK Ventilator, Continuous, Facility Use Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30606959024602 Package GS1 10 Not in Commercial Distribution 00606959024601 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30606959024602 30606959024602 00606959024601 00606959024601 606959024601 0606959024601
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP face mask, single-use A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Storage Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 080728314 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00606959055735 Sleepware G3 Sleepware G3 2026-01-22 00606959060586 Care Orchestrator Care Orchestrator 2026-01-22 00606959424852 DreamStation BiPAP autoSV DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AUX900T15C 2017-02-01 00606959424944 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, AUX1131H15C 2017-02-10 00606959424951 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 AE w/Cell, AU AUX1131S15C 2017-02-10 00606959424968 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Ce AUX1131T15C 2017-02-10 00606959424975 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AUX1131H15W 2017-02-10 00606959424982 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 AE w/WiFi, AU AUX1131S15W 2017-02-10 00606959424999 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/W AUX1131T15W 2017-02-10 00606959425378 DreamStation 01 CNX1130T17 2019-12-29 00606959425385 DreamStation 01 CNX1131H17 2019-12-29 00606959425392 DreamStation 01 CNX1131S17 2019-12-29 00606959425408 DreamStation 01 CNX1131T17 2019-11-20 00606959425484 DreamStation BiPAP autoSV DreamStation BiPAP autoSV w/Humid w/H Tube, w/Cell CAX900T12C 2017-02-01 00606959425491 DreamStation BiPAP autoSV DreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFi CAX900T12W 2017-02-01 00606959425538 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CA CAX1130H12C 2017-02-10 00606959425545 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Cell, CA CAX1130S12C 2017-02-10 00606959425552 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Humid w/H Tube w/Cell CAX1130T12C 2017-02-10 00606959425569 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CA CAX1130H12W 2017-02-10 00606959425576 DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/WiFi, CA CAX1130S12W 2017-02-10
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