FDA.report

Yeso med

Primary DI
06971352284797
Brand
Yeso med
Company
WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
Model
10ml 0.6×25
Device description
Safety syringe with needle
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FMFSyringe, Piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971352284797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971352284797069713522847976971352284797

GMDN Terms

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

Regulatory Flags

DUNS number
418798733
Device count
1
DM exempt
false
Premarket exempt
false
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 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
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

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