FDA.reportPublic FDA data

Vital Signs™

Primary DI
10190752136434
Brand
Vital Signs™
Company
Vyaire GmbH
Model
M1035991
Catalog number
M1035991
Device description
Patient Circuit, Expandable, Pediatric, Disposable, 1.8 m/72 in
Published
2021-04-02
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
CAHFilter, bacterial, breathing-circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70190752136436PackageGS120In Commercial Distribution
10190752136434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7019075213643670190752136436
1019075213643410190752136434

GMDN Terms#

Term, Definition table
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.

Contacts#

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

Regulatory Flags#

DUNS number
313793199
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752111349Vital Signs™78010780102021-04-02
20190752111346Vital Signs™78010780102021-04-02
70190752136436Vital Signs™M1035991M10359912021-04-02
20190752139586Vital Signs™M1087562M10875622021-04-02

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Primary DI, Brand, Company table
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