FDA.reportPublic FDA data

Vital Signs™

Primary DI
10889483592687
Brand
Vital Signs™
Company
AIRLIFE
Model
A4V16XX4T
Catalog number
A4V16XX4T
Device description
Adult Anesthesia Breathing Circuit
Published
2025-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
30889483592681PackageGS120In Commercial Distribution
10190752160392PreviousGS10
10889483592687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948359268130889483592681
1019075216039210190752160392
1088948359268710889483592687

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 artificial airway/respiratory mask (not included). 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 a carbon dioxide cuvette and/or 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.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752118379Vital Signs™2L39882L39882019-12-20
10190752118430Vital Signs™5030AE5030AE2020-02-20
10190752118973Vital Signs™5236AAE5236AAE2019-12-20
10190752119017Vital Signs™5372AE5372AE2019-12-20
10190752119215Vital Signs™A1UXOXXXA1UXOXXX2019-12-20
10190752119246Vital Signs™A1ZX1XXXA1ZX1XXX2020-02-20
10190752119369Vital Signs™A46517XXA46517XX2019-12-20
10190752119437Vital Signs™A46X8XXXA46X8XXX2019-12-20
10190752119628Vital Signs™A4FX1XXXA4FX1XXX2019-12-20
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20
10190752120013Vital Signs™A4UX204XA4UX204X2019-12-20
10190752120020Vital Signs™A4UX20X4A1A4UX20X4A12019-12-20
10190752120174Vital Signs™A4UX8XXXA4UX8XXX2019-12-20
10190752120747Vital Signs™A5U52X14A5U52X142019-12-20
10190752120914Vital Signs™A5Z1XXXXA5Z1XXXX2019-12-20
10190752121065Vital Signs™A8F11XXXA8F11XXX2020-02-20
10190752121072Vital Signs™A8FX804XA8FX804X2019-12-20
10190752121096Vital Signs™A8T52914A8T529142019-12-20
10190752121140Vital Signs™A8U52X14A8U52X142019-12-20
10190752121188Vital Signs™A8UX19XXA8UX19XX2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10680651497571HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497588HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497595HalyardO&M HALYARD, INC.OFP2026-06-06
10198956137240CARDINAL HEALTHCardinal Health 200, LLCOFP2025-08-11
10889483597422Vital Signs™AIRLIFEOFP2025-03-27
10889483592748Vital Signs™AIRLIFEOFP2025-03-07
10889483599969Vital Signs™AIRLIFEOFP2025-03-07
10889483580035AirLife™AIRLIFEOFP2025-02-20
10889483581513AirLife™AIRLIFEOFP2025-02-20
10889483581520AirLife™AIRLIFEOFP2025-02-20
10889483584118AirLife™AIRLIFEOFP2025-02-20
10889483584125AirLife™AIRLIFEOFP2025-02-20
10889483598207Vital Signs™AIRLIFEOFP2025-02-19
10889483595145Vital Signs™AIRLIFEOFP2025-02-18
10889483595596Vital Signs™AIRLIFEOFP2025-02-18
10889483595855AirLife™AIRLIFEOFP2025-02-18
10889483595886AirLife™AIRLIFEOFP2025-02-18
10889483595909AirLife™AIRLIFEOFP2025-02-18
10889483597484Vital Signs™AIRLIFEOFP2025-02-18
10889483584330AirLife™AIRLIFEOFP2025-02-17
10889483584354AirLife™AIRLIFEOFP2025-02-17
10889483584361AirLife™AIRLIFEOFP2025-02-17
10889483584378AirLife™AIRLIFEOFP2025-02-17
10889483584385AirLife™AIRLIFEOFP2025-02-17
10889483596456Vital Signs™AIRLIFEOFP2025-02-17
10889483597699Vital Signs™AIRLIFEOFP2025-02-17
10889483600177Vital Signs™AIRLIFEOFP2025-02-17
10889483600320Vital Signs™AIRLIFEOFP2025-02-17
10889483592588Vital Signs™AIRLIFEOFP2025-02-13
10889483593356Vital Signs™AIRLIFEOFP2025-02-13