Catalog Number

06 0508

Brand Name

SAFE-T-FILL®

Version/Model Number

06 0508

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

GHY

Product Code Name

HEMATOCRIT, TUBE, RACK, SEALER, HOLDER

Public Device Record Key

e7a40259-b6d3-4da3-a2f3-f27c73a6da8e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

30643351000384

Quantity per Package

10

Contains DI Package

10643351000380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE