FDA.report

inspired™

Primary DI
14896138001049
Brand
inspired™
Company
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Model
2096534-003
Device description
PATIENT TUBE,ADULT,REUSABLE,HYTREL,0.9m
Published
2020-09-18
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
false

Related Records

Product Codes

CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04896138009581Direct MarkingGS10
64896138001044PackageGS150In Commercial Distribution
14896138001049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04896138009581048961380095814896138009581
6489613800104464896138001044
1489613800104914896138001049

GMDN Terms

TermDefinition
Anaesthesia breathing circuit, reusableAn 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 reusable device.

Regulatory Flags

DUNS number
663901361
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
14896138000899inspired™2096533-0042020-09-18
14896138000905inspired™2096534-0012020-09-18
14896138000912inspired™2096534-0022020-09-18
14896138000929inspired™2096534-0052020-09-18
14896138000936inspired™2096534-0062020-09-18
14896138000943inspired™2096534-0072020-09-18
14896138000950inspired™2096534-0082020-09-18
14896138000967inspired™2096534-0092020-09-18
14896138001018inspired™2096534-1032020-09-18
14896138001025inspired™2096536-0012020-09-18
14896138001056inspired™2096534-0042020-09-18
14896138001063inspired™2096534-1042020-09-18
14896138001100inspired™2096534-1012020-09-18
14896138001117inspired™2096534-1022020-09-18
64896138000863inspired™2096533-0012020-09-18
64896138000870inspired™2096533-0022020-09-18
14896138000882inspired™2096533-0032020-09-18
64896138000894inspired™2096533-0042020-09-18
64896138000900inspired™2096534-0012020-09-18
64896138000917inspired™2096534-0022020-09-18

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