FDA.reportPublic FDA data

AirLife™

Primary DI
50190752156898
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
10836-504
Catalog number
10836-504
Device description
Isothermal™ Breathing Circuit Accessory
Published
2021-04-02
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
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752156898PackageGS120In Commercial Distribution
10190752156890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215689850190752156898
1019075215689010190752156890

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. 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
true
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
10190752190535LTV10611106112025-08-26
10190752191518bellavista301.115.010301.115.0102025-07-28
10190752188860bellavista301.115.000301.115.0002025-07-25
10190752191525bellavista301.115.020301.115.0202025-07-25
10190752130364LTV2 Ventilator30509-00130509-0012025-07-16
201907522010613100A HFOV7671637671632025-07-16
10190752185197LTV228774-00128774-0012025-07-16
10190752188754LTV2 Ventilator24425-00124425-0012025-07-16
10190752188761LTV2 Ventilator24426-00124426-0012025-07-16
10190752188808LTV2 Ventilator30512-00130512-0012025-07-16
10190752190368LTV2 Ventilator29242-00129242-0012025-07-16
10190752187818iFlow301.328.020301.328.0202024-11-05
50190752187823iFlow301.328.020301.328.0202024-11-05
50190752200805LTV29660-00129660-0012024-11-05
50190752200829LTV29701-00129701-0012024-11-05
101907522010193100 HFOV11438-PMN11438-PMN2024-11-05
10190752201118LTV10696106962024-11-05
50190752201536LTV11872x1011872x102024-11-05
50190752200751LTV29659-00129659-0012024-08-13
10190752201446LTV15091-10215091-1022024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE Intersurgical IncorporatedBZE2025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6MIntersurgical IncorporatedBZE2025-04-16
30889483572126AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573383AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573802AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483605480AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616932AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616956AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
0503026703366922MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709791322MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703368322MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709637422MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703367622MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6MIntersurgical IncorporatedBZE2025-03-14
0503026716192822MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
30889483584105AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483588356AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483595842AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483615618AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
10889483616963AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483586529AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587137AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587328AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483591288AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483572652AirLife™Sunmed Group Holdings, LLCBZE2025-03-05
30889483572904AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483616994AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483617007AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
30889483581043AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581081AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581135AirLife™Sunmed Group Holdings, LLCBZE2025-02-21