AmerisourceBergen - Fecal Diagnostic Kit Refill, Disposable, - BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Duns Number:985523874

Device Description: Fecal Diagnostic Kit Refill, Disposable, Non-sterile

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More Product Details

Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11504

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

NNK

Product Code Name

Container, Specimen Mailer And Storage, Non-Sterile

Device Record Status

Public Device Record Key

9c1fcf6b-e1f2-4f5f-8454-494cba70aec3

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

60368001115041

Quantity per Package

8

Contains DI Package

00368001115049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2