FDA.reportPublic FDA data

AF541

Primary DI
30606959024671
Brand
AF541
Company
Respironics, Inc.
Model
00
Catalog number
1121081
Device description
AF541 SE WITH CAPSTRAP, X-LARGE
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVENTILATOR, CONTINUOUS, FACILITY USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30606959024671PackageGS110Not in Commercial Distribution
00606959024670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060695902467130606959024671
00606959024670006069590246706069590246700606959024670

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA 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
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com

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 DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850057117370RESPOND VentilatorCORVENT MEDICAL, INCCBK2026-01-06
00850057117387Flow SensorCORVENT MEDICAL, INCCBK2026-01-06
00850057117394RESPOND Exhalation ManifoldCORVENT MEDICAL, INCCBK2026-01-06
00850057117400Exhalation ValveCORVENT MEDICAL, INCCBK2026-01-06
00850057117417RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/CORVENT MEDICAL, INCCBK2026-01-06
00850057117424HEPA FiltersCORVENT MEDICAL, INCCBK2026-01-06
00850057117448Green Oxygen Hose, 8ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117455Oxygen Tubing with Connector, 7ftCORVENT MEDICAL, INCCBK2026-01-06
00850057117462Cart, IV Power StripCORVENT MEDICAL, INCCBK2026-01-06
00850057117479Cart, IV Power Strip MountCORVENT MEDICAL, INCCBK2026-01-06
00850057117486Patient Circuit Arm ClipCORVENT MEDICAL, INCCBK2026-01-06
00850070543033Emergency Ventilator Complete PackageVentis Medical Inc.CBK2025-12-31
00853678006733pNeuton Model A with 6ft Patient CircuitAIRON CORPORATIONCBK2025-12-19
20197344102652MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102669MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102676MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102683MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102690MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
20197344102706MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477507F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477514F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477521F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480453F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CBK2025-12-02
06903053046022VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
06903053046060VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.CBK2025-11-29
10190752190535LTVVYAIRE MEDICAL, INC.CBK2025-08-26
00850018761413Internal Battery PM Upgrade USB DriveVENTEC LIFE SYSTEMS, INC.CBK2025-08-06