McKesson - Over-the-Head Protective Procedure Gown CPE , - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Over-the-Head Protective Procedure Gown CPE , FLUID RESISTANT OVERHEAD, THUMB LOOP CUFF Over-the-Head Protective Procedure Gown CPE , FLUID RESISTANT OVERHEAD, THUMB LOOP CUFF , APRON CLOSURE , BLUE LARGE

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-OHBCPE

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)

-

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Device Record Status

Public Device Record Key

ebe7063d-f678-4f81-894b-f543d511eac0

Public Version Date

October 30, 2019

Public Version Number

1

DI Record Publish Date

October 22, 2019

Additional Identifiers

Package DI Number

00612479203143

Quantity per Package

6

Contains DI Package

00612479203136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MCKESSON MEDICAL-SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 870
2 A medical device with a moderate to high risk that requires special controls. 422
U Unclassified 44