FDA.reportPublic FDA data

CareTouch

Primary DI
06975442097953
Brand
CareTouch
Company
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
Model
3ml 0.8×25
Device description
Disposable syringe Luer lock with needle
Published
2022-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975442097953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975442097953069754420979536975442097953

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418798733
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971352286128Yeso-med1ml 0.4×12.72022-08-23
06975442097878CareTouch1ml 2022-08-23
06975442097885CareTouch1ml 2022-08-23
06975442097892CareTouch3ml2022-08-23
06975442097908CareTouch3ml 2022-08-23
06975442097915CareTouch5ml2022-08-23
06975442097922CareTouch5ml 2022-08-23
06975442097939CareTouch10ml2022-08-23
06975442097946CareTouch10ml 2022-08-23
06975442097960CareTouch3ml 0.8×382022-08-23
06975442097977CareTouch3ml 0.9×252022-08-23
06975442097984CareTouch3ml 0.9×382022-08-23
06975442097991CareTouch3ml 0.6×252022-08-23
06975442098004CareTouch3ml 0.6×382022-08-23
06975442098011CareTouch3ml 0.5×162022-08-23
06975442098028CareTouch3ml 0.5×252022-08-23
06975442098035CareTouch3ml 0.5×382022-08-23
06975442098042CareTouch3ml 0.45×252022-08-23
06975442098059CareTouch3ml 0.45×382022-08-23
06975442098066CareTouch3ml 0.4×122022-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMF2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08699207302028Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207305036Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207310030Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207311006Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207320022Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08699207350029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
08800045101890Feel Ject(FIS-019, U-100, 0.3cc, 32G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045102040Feel Ject(FIS-024, U-100, 0.5cc, 32G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045102194Feel Ject(FIS-029, U-100, 1.0cc, 32G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-02-06
08800045102521Feel Ject(FIS-039, U-100, 0.3cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-02-06