V. Mueller - ESMARK BANDAGE 4IN X 9FT 20/BX - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: ESMARK BANDAGE 4IN X 9FT 20/BX

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More Product Details

Catalog Number

014.00

Brand Name

V. Mueller

Version/Model Number

014.00

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

FQM

Product Code Name

BANDAGE, ELASTIC

Device Record Status

Public Device Record Key

56424187-3370-459d-8442-9cacf4bd8b13

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 12, 2018

Additional Identifiers

Package DI Number

20885403206426

Quantity per Package

20

Contains DI Package

10885403206429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CAREFUSION 2200, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8016
2 A medical device with a moderate to high risk that requires special controls. 6223