FDA.reportPublic FDA data

AirLife™

Primary DI
50190752155501
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
70004027
Catalog number
70004027
Device description
ABG Accessories
Published
2022-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFPAnesthesia breathing circuit kit (adult & pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752155501PackageGS11000In Commercial Distribution
10190752155503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215550150190752155501
1019075215550310190752155503

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. 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
true
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
false
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
00850070635035Breathing Circuit KitNar Medical Depot, LLCOFP2025-12-01
50198956137248CARDINAL HEALTHCardinal Health 200, LLCOFP2025-08-11
04048675695622Anesthesia Circuit Kit Coax HEPADrägerwerk AG & Co. KGaAOFP2025-05-19
04048675695639Anesthesia Circuit Kit Flex HEPADrägerwerk AG & Co. KGaAOFP2025-05-19
0503026716154622mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
0503026716175122mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
10889483583388Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587072Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587089Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587096Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587102Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587119Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587126Vital Signs™AirLife Finland OyOFP2025-04-14
10889483590072Vital Signs™AirLife Finland OyOFP2025-04-14
00816472022972Multipac UniFlow anesthesia breathing systemIntersurgical IncorporatedOFP2025-04-11
10841470106215ABC -Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106260ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106284ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106345ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106574ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106581ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106734ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470107113ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470107656ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108622ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108738ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108844ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108943ABC - Duoflow Bi-lumen Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470108950ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470109452ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11