FDA.reportPublic FDA data

AirLife™

Primary DI
50190752139952
Brand
AirLife™
Company
Vyaire Medical Oy
Model
M1010534
Device description
Angled HMEF 1000/S
Published
2019-09-01
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
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752139952PackageGS150In Commercial Distribution
10190752139954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075213995250190752139952
1019075213995410190752139954

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-327-3318customersupport@vyaire.com

Regulatory Flags#

DUNS number
368457563
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20190752141251Multi-Link™2086367-0032086367-0032021-01-14
20190752141268Multi-Link™2086367-0042086367-0042021-01-14
20190752101729Multi-Link™2086367-0062086367-0062021-01-14
70190752191237Vital Signs™M1031274M10312742023-05-30
50190752117912Vital Signs™7331882019-09-01
50190752117929Vital Signs™7331992019-09-01
50190752117172Vital Signs™73318-HEL2019-09-01
50190752117189Vital Signs™73319-HEL2019-09-01
50190752117493Vital Signs™733062019-09-01
20190752188188Vital Signs™2464AAO-202464AAO-202022-03-18
70190752139840AirLife™5570195002019-09-01
70190752139857AirLife™5570701002019-09-01
70190752139864AirLife™5570705002019-09-01
70190752139871AirLife™5570707002019-09-01
70190752139888AirLife™5570715002019-09-01
70190752139895AirLife™5570716002019-09-01
70190752139901AirLife™5570855002019-09-01
70190752139918AirLife™80042312019-09-01
70190752139925AirLife™85702032019-09-01
70190752139932AirLife™M10041322019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632520365HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-30
00848530110086Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-27
10885632520341HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520358HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520327HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
10885632520334HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
20885632532129HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
00848530093686Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-19
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-06-23
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10889483231715Pro-Nox Medium Disposable KitSUNMED, LLCCAH2025-12-15
00848530089115Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089139Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089108Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530093839Cough Assist KitSunset Healthcare Solutions, Inc.CAH2025-05-21