FDA.reportPublic FDA data

AF421

Primary DI
00606959008410
Brand
AF421
Company
Respironics, Inc.
Model
AF421 Mask with Entrainment Elbow, Leak 1, XLarge,
Catalog number
1119050
Device description
AF421 Mask with Entrainment Elbow, Leak 1, XLarge, International
Published
2015-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30606959008411PackageGS110Not in Commercial Distribution
40606959008418PackageGS120Not in Commercial Distribution
00606959008410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060695900841130606959008411
4060695900841840606959008418
00606959008410006069590084106069590084100606959008410

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-4 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
080728314
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959015203REMSTAR PASSOVER HUMIDIFIERREMstar Passover Humidifier10060872018-06-26
00606959015210Replacement Part 24 Inch Grey Tubing0010068332018-06-30
00606959055735Sleepware G3Sleepware G32026-01-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814747025017Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025024Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025031Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025048Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025055Ascend Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025062Ascend Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025079Ascend Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025086Ascend Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025093Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025109Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025116Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025123Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025130Ascend Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025147Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025154Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025161Ascend Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025178IQ 2 Nasal MaskSLEEPNET, CORP.BZD2026-10-23
00814747025185Phantom 2 Nasal Vented MaskSLEEPNET, CORP.BZD2026-10-23
00814747025192MiniMe 2 Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-10-23
00814747025208MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025215MiniMe 2 Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025222MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025314Novaplus Full Face Vented Mask, Extra LargeSLEEPNET, CORP.BZD2026-10-23
00814747025321Novaplus Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025338Novaplus Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025345Novaplus Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025352Novaplus Hospital Nasal Non Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025369Novaplus Hospital Nasal Non Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23
00814747025376Novaplus Hospital Nasal Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025383Novaplus Hospital Nasal Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23