FDA.reportPublic FDA data

AirLife™

Primary DI
50190752156034
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
2K8085
Catalog number
2K8085
Device description
Large AirLifeSeeBreath CO2Detector
Published
2021-05-03
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752156034PackageGS110In Commercial Distribution
10190752156036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075215603450190752156034
1019075215603610190752156036

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide sensor/cableAn assembly of electrical wires with a detector (typically infrared spectroscopic) at the distal end designed to connect a carbon dioxide (CO2) cuvette, or other form of translucent window placed in an anaesthetic or ventilatory breathing circuit, with a CO2 patient monitor, for the transmission of electrical signals to measure the CO2 concentration in gases expired by the patient. The proximal end of the device typically has a multi-pinned plug for insertion into the patient monitor. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature-10 Degrees Celsius30 Degrees Celsius

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
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
20889483226435Bell Medical CannulaSALTER LABSCCK2026-03-13
04048675448884Sample Line Set (10pcs)Drägerwerk AG & Co. KGaACCK2026-02-16
20889483230555AirLife™SUNMED, LLCCCK2025-12-31
20889483221157AirLife™SUNMED, LLCCCK2025-12-18
20889483222390AirLife™SUNMED, LLCCCK2025-12-18
20889483230364AirLife™SUNMED, LLCCCK2025-12-18
10885403520761BD Alaris™ ETCO2 Module, Model 8300CAREFUSION 303, INC.CCK2025-09-10
15055140702804MediplusMEDIPLUS LTDCCK2025-08-29
00810094579562Curaplex®BOUND TREE MEDICAL, LLCCCK2025-08-06
00810094579579Curaplex®BOUND TREE MEDICAL, LLCCCK2025-08-06
30889483236325Iradimed Adult Capnography CannulaSALTER LABSCCK2025-08-04
30889483236332Iradimed Infant Capnography CannulaSALTER LABSCCK2025-08-04
30889483236349Iradimed Pediatric Capnography CannulaSALTER LABSCCK2025-08-04
30889483236356IradimedSALTER LABSCCK2025-08-04
30889483236363IradimedSALTER LABSCCK2025-08-04
30889483236370IradimedSALTER LABSCCK2025-08-04
30889483236387IradimedSALTER LABSCCK2025-08-04
30889483236318Iradimed Sample Line ExtensionSALTER LABSCCK2025-08-04
09555866300876DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
20885632455442Halyard Gas Sampling LineAIRLIFECCK2025-07-25
10885632455452Halyard Gas Sampling LineAIRLIFECCK2025-07-25
20888277420592MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-06-13
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00840117342385Resp-O2 EtCO2 Nasal Sampling Cannula, 14" (4.2 m ) O2 and CO2 Tubing Dynarex CorporationCCK2025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO2Dynarex CorporationCCK2025-06-09
20884389815318MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
20884389815066MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
20889483600501Vital Signs™AirLife Finland OyCCK2025-04-02
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20889483600518Vital Signs™AirLife Finland OyCCK2025-03-31