Catalog Number

01-120000.B1

Brand Name

D3 Fastpoint

Version/Model Number

01-120000.B1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091171

Product Code

GNS

Product Code Name

ANTISERA, HAI, INFLUENZA VIRUS A, B, C

Public Device Record Key

af124d63-dbd3-45ea-bc6e-d00689a74cb0

Public Version Date

August 22, 2018

Public Version Number

1

DI Record Publish Date

July 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-