Duns Number:602759672
Device Description: SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Dipotassium EDTA; Sel SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Dipotassium EDTA; Self-sealing Cap, Purple
Catalog Number
07 6013
Brand Name
SAFE-T-FILL®
Version/Model Number
07 6013
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"
Yes
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
K981973,K981973,K981973,K981973
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
dd347dcb-76f4-4ce2-88b0-795d23156d90
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
30643351000025
Quantity per Package
10
Contains DI Package
10643351000021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |