FDA.reportPublic FDA data

CareTouch

Primary DI
06975442097960
Brand
CareTouch
Company
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
Model
3ml 0.8×38
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
06975442097960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975442097960069754420979606975442097960

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
06975442097953CareTouch3ml 0.8×252022-08-23
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

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