FDA.reportPublic FDA data

inspired™

Primary DI
64896138000917
Brand
inspired™
Company
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Model
2096534-002
Device description
PATIENT TUBE,ADULT,REUSABLE,HYTREL,0.75m
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
64896138000917PackageGS15In Commercial Distribution
14896138000912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6489613800091764896138000917
1489613800091214896138000912

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.

Sterilization Methods#

Method table
Method

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
44710810083325N/AGALEMED CORPORATIONCAI2026-03-05
44710810085558N/AGALEMED CORPORATIONCAI2026-03-05
44710810087682N/AGALEMED CORPORATIONCAI2026-03-05
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
00612649130972JACKSON REESKing Systems CorporationCAI2023-01-18
00612649214047UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214030UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214078UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214092UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214115UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214139UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18
00612649214153UNIVERSAL F® FLEX2®King Systems CorporationCAI2023-01-18