MEDI - 30-40 MV HARMONY ARMSLV GNTL TB BLACK I - MEDI MANUFACTURING, INC.

Duns Number:960754430

Device Description: 30-40 MV HARMONY ARMSLV GNTL TB BLACK I

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More Product Details

Catalog Number

-

Brand Name

MEDI

Version/Model Number

2Z11501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2020

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

DWL

Product Code Name

Stocking, medical support (to prevent pooling of blood in legs)

Device Record Status

Public Device Record Key

3105ae86-1874-400f-a394-53f8a6e1db0f

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDI MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2971
2 A medical device with a moderate to high risk that requires special controls. 9550