NA - Transparent Film (PU Film, Non-Sterile) - Henan Maidingkang Medical Technology Co., Ltd.

Duns Number:724981491

Device Description: Transparent Film (PU Film, Non-Sterile)

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

Non-Sterile

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

KMK

Product Code Name

Device, Intravascular Catheter Securement

Device Record Status

Public Device Record Key

8afc7e36-6a1f-4a1e-ac73-22fd97ad2349

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Additional Identifiers

Package DI Number

16974795050186

Quantity per Package

40

Contains DI Package

06974795050189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HENAN MAIDINGKANG MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14