Catalog Number

06 0199

Brand Name

SAFE-T-FILL®

Version/Model Number

06 0199

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

-

Product Code

GIO

Product Code Name

TUBE, COLLECTION, CAPILLARY BLOOD

Public Device Record Key

9f52ff93-38d8-462d-931d-ef44eaa75c56

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 01, 2022

Package DI Number

30643351000322

Quantity per Package

4

Contains DI Package

10643351000328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE