FDA.report

Vital Signs™

Primary DI
50190752123173
Brand
Vital Signs™
Company
VYAIRE MEDICAL, INC.
Model
AXXXX171
Catalog number
AXXXX171
Device description
Vital Signs™ Adult Anesthesia Breathing Circuit
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OFPAnesthesia breathing circuit kit (adult & pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50190752123173PackageGS120In Commercial Distribution
10190752123175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019075212317350190752123173
1019075212317510190752123175

GMDN Terms

TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Sterilization Methods

Method

Contacts

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
true
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

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Other Devices Sharing Product Codes

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
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10841470106260ABC - Uniflow Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
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10841470106345ABC - Flex Tube SystemENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
10841470106574ABC - Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
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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
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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
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