FDA.reportPublic FDA data

Vital Signs™

Primary DI
10190752110731
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
412342-001
Catalog number
412342-001
Device description
Vital Signs CAPNOSTAT Pediatric/Infant Airway Adapter, Reusable
Published
2020-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403257018PreviousGS10
10190752110731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540325701810885403257018
1019075211073110190752110731

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide cuvette, reusableA device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is typically designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor that is slotted over the outside of the window section. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
368457563
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752139749AirLife™85702302019-09-01
10889483590591AirLife™857023085702302025-04-02
10190752140912Vital Signs™M1031274M10312742021-01-28
10190752145641Vital Signs™M1031273M10312732021-07-06
10190752191235Vital Signs™M1031274M10312742023-05-30
10190752125582Vital Signs™2025248-0012025248-0012018-11-23
10190752125599Vital Signs™2025248-0022025248-0022018-11-23
10190752125629Vital Signs™9446-9119446-9112018-11-23
10190752125636Vital Signs™9446-9139446-9132018-11-23
10190752181380Vital Signs™9446-9119446-9112020-12-15
10190752181397Vital Signs™9446-9139446-9132020-12-15
10190752179349Vital Signs™2025248-0012025248-0012020-12-01
10190752179356Vital Signs™2025248-0022025248-0022020-12-01
10889483587881AirLife™6600-0196-7006600-0196-7002025-03-26
10889483587904AirLife™6600-0208-7006600-0208-7002025-03-26
10889483590003AirLife™800423180042312025-04-02
10889483590584AirLife™857020385702032025-04-02
10889483601563AirLife™M1010534M10105342025-04-02
10889483602522AirLife™M1038637M10386372025-03-31
10889483603222Vital Signs™M1138830M11388302025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10889483225257AirLife™SUNMED, LLCBZA2025-12-22
10889483225226Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
10889483225271AirLife™SUNMED, LLCBZA2025-12-18
10889483225660AirLife™SUNMED, LLCBZA2025-12-18
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
10884521084995DARCovidien LPBZA2025-04-12
10884521842533DARCovidien LPBZA2025-04-12
10884522019743DARCovidien LPBZA2025-04-12
10884522019750DARCovidien LPBZA2025-04-12
10884522019774DARCovidien LPBZA2025-04-12
10884522019781DARCovidien LPBZA2025-04-12
10884522019804DARCovidien LPBZA2025-04-12
10884522019811DARCovidien LPBZA2025-04-12
10884522019828DARCovidien LPBZA2025-04-12
10884522019835DARCovidien LPBZA2025-04-12
10884522019842DARCovidien LPBZA2025-04-12
10884522019859DARCovidien LPBZA2025-04-12
10884522019866DARCovidien LPBZA2025-04-12
10884522019873DARCovidien LPBZA2025-04-12
10884522019880DARCovidien LPBZA2025-04-12
10884522019897DARCovidien LPBZA2025-04-12