V. Mueller - Genesis Tamper-Evident Arrows (Gas) - YELLOW - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: Genesis Tamper-Evident Arrows (Gas) - YELLOW

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More Product Details

Catalog Number

AG2-2

Brand Name

V. Mueller

Version/Model Number

AG2-2

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Device Record Status

Public Device Record Key

a0a8e3c3-4c78-464e-9f26-fea4bbcd81e2

Public Version Date

January 15, 2019

Public Version Number

3

DI Record Publish Date

August 11, 2017

Additional Identifiers

Package DI Number

50885403160385

Quantity per Package

40

Contains DI Package

20885403160384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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