Catalog Number

07 7340

Brand Name

SAFE-T-FILL®

Version/Model Number

07 7340

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

K983517,K983517,K983517,K983517

Product Code

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

9b2014d8-f3f4-419c-a118-95eb50cd0d1f

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

50643351000135

Quantity per Package

80

Contains DI Package

10643351000137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON