FDA.reportPublic FDA data

AirLife™

Primary DI
50190752156461
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
2K80273
Catalog number
2K80273
Device description
1 Liter Neoprene Flow-Inflating Bag with Pre-Attached 7’ (2.1 m) Oxygen Tubing, Manometer and Pediatric Valved Mask
Published
2021-05-03
Public version status
New
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
BZRMixer, breathing gases, anesthesia inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752156461PackageGS120In Commercial Distribution
10190752156463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215646150190752156461
1019075215646310190752156463

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752129993LTV11581-G11581-G2021-02-22
10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15
10190752114975AirLife™0025010025012020-01-15
10190752114982AirLife™0025020025022020-01-15
10190752114999AirLife™0025300025302020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260635790660AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790776AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790783AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790790AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
10889483528600AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528723AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528747AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528853AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483528938AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542774AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542798AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542835AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542859AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542873AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542910AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483542958AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483528614AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
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20889483568795AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
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20889483542863AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542887AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542924AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
20889483542962AMBU Hyperinflation SystemWESTMED, INC.BZR2026-03-05
10889483222157AmbuSUNMED, LLCBZR2025-12-19
10889483222164AmbuSUNMED, LLCBZR2025-12-19