FDA.reportPublic FDA data

inspired™

Primary DI
14896138000929
Brand
inspired™
Company
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Model
2096534-005
Device description
PATIENT CIRCUIT KIT,ADULT,REUSABLE,HYTREL,WATER TRAP
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

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04896138009604Direct MarkingGS10
64896138000924PackageGS110In Commercial Distribution
14896138000929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04896138009604048961380096044896138009604
6489613800092464896138000924
1489613800092914896138000929

GMDN Terms#

Term, Definition table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14896138000899inspired™2096533-0042020-09-18
14896138000905inspired™2096534-0012020-09-18
14896138000912inspired™2096534-0022020-09-18
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
14896138001049inspired™2096534-0032020-09-18
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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44710810088559N/AGALEMED CORPORATIONCAI2026-03-05
44710810101319N/AGALEMED CORPORATIONCAI2026-03-05
44710810103504N/AGALEMED CORPORATIONCAI2026-03-05
44710810105720N/AGALEMED CORPORATIONCAI2026-03-05
44710810105737N/AGALEMED CORPORATIONCAI2026-03-05
44710810110915N/AGALEMED CORPORATIONCAI2026-03-05
44710810116108N/AGALEMED CORPORATIONCAI2026-03-05
44710810080867N/AGALEMED CORPORATIONCAI2026-03-04
44710810087859N/AGALEMED CORPORATIONCAI2026-03-04
44710810088474N/AGALEMED CORPORATIONCAI2026-03-04
44710810089808N/AGALEMED CORPORATIONCAI2026-03-04
44710810103146N/AGALEMED CORPORATIONCAI2026-03-04
44710810114098N/AGALEMED CORPORATIONCAI2026-03-04
44710810116092N/AGALEMED CORPORATIONCAI2026-03-04
44710810116924N/AGALEMED CORPORATIONCAI2026-03-04
20889483300135Respan®SUNMED, LLCCAI2026-02-11
46923980110359N/AGaleMed Xiamen Co., Ltd.CAI2026-02-05
M368H0678972HAUSTEDGF HEALTH PRODUCTS, INC.CAI2025-10-31
00612649214559UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
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00612649214047UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214030UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
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00612649214092UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
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00612649214139UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214153UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18