FDA.reportPublic FDA data

inspired™

Primary DI
14896138001100
Brand
inspired™
Company
VINCENT MEDICAL MANUFACTURING CO., LIMITED
Model
2096534-101
Device description
PATIENT TUBE,ADULT,REUSABLE,SILICONE,1m
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
04896138011652Direct MarkingGS10
64896138001105PackageGS125In Commercial Distribution
14896138001100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04896138011652048961380116524896138011652
6489613800110564896138001105
1489613800110014896138001100

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

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
14896138016692inspired™2096534-1052026-08-05
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
14896138001117inspired™2096534-1022020-09-18
14896138000868inspired™2096533-0012020-09-18
14896138000875inspired™2096533-0022020-09-18
14896138000974inspired™2096535-0012020-09-18
14896138000998inspired™2096536-0032020-09-18
14896138001001inspired™2096536-0042020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
10889483584705Vital Signs™AIRLIFECAI2025-03-06
10889483591666Vital Signs™AIRLIFECAI2025-02-18
10889483591925Vital Signs™AIRLIFECAI2025-02-18
10889483591987Vital Signs™AIRLIFECAI2025-02-18
10889483592113Vital Signs™AIRLIFECAI2025-02-18
10889483592496Vital Signs™AIRLIFECAI2025-02-18
10889483592656Vital Signs™AIRLIFECAI2025-02-18
10889483593448Vital Signs™AIRLIFECAI2025-02-18
10889483593561Vital Signs™AIRLIFECAI2025-02-18
10889483593660Vital Signs™AIRLIFECAI2025-02-18
10889483593752Vital Signs™AIRLIFECAI2025-02-18
10889483585627Vital Signs™AIRLIFECAI2025-02-17
10889483585801Vital Signs™AIRLIFECAI2025-02-17
10889483584699Vital Signs™AIRLIFECAI2025-02-11
10889483592175Vital Signs™AIRLIFECAI2025-02-11