BD Multitest - BD Multitest™ 6-Color TBNK - BECTON, DICKINSON AND COMPANY

Duns Number:024230633

Device Description: BD Multitest™ 6-Color TBNK

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More Product Details

Catalog Number

662967

Brand Name

BD Multitest

Version/Model Number

662967

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

-

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

K090967

Product Code Details

Product Code

GKZ

Product Code Name

Counter, differential cell

Device Record Status

Public Device Record Key

1c18d6d4-748b-4fcc-b187-019385835d0b

Public Version Date

February 11, 2022

Public Version Number

4

DI Record Publish Date

December 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4