TKMD - The piston syringe is a device intended for - Anhui Tiankang Medical Technology Co., Ltd.

Duns Number:527035248

Device Description: The piston syringe is a device intended for medical purposes, consisting of a calibrated h The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip /lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.

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More Product Details

Catalog Number

-

Brand Name

TKMD

Version/Model Number

TKSLL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

2fd77737-7f5b-42be-b5c5-4a4e89951186

Public Version Date

February 17, 2021

Public Version Number

2

DI Record Publish Date

February 04, 2021

Additional Identifiers

Package DI Number

16934841565088

Quantity per Package

100

Contains DI Package

06934841565081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1