Catalog Number

OVKG03

Brand Name

BFT II Analyzer Dispo System

Version/Model Number

10446530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K984501,K984501

Product Code

JPA

Product Code Name

SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Public Device Record Key

334108fd-1ec9-4bd6-925f-aa991a1dae14

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

October 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-