Duns Number:602759672
Device Description: SAFE-T-FILL® Capillary Blood Collection Microtubes, 1 mL; Prepared with Lithium Heparin an SAFE-T-FILL® Capillary Blood Collection Microtubes, 1 mL; Prepared with Lithium Heparin and Plasma Separator Gel; Green
Catalog Number
07 8021
Brand Name
SAFE-T-FILL®
Version/Model Number
07 8021
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
44aa1e8a-f3c0-49b8-9622-2d64da554705
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
30643351000216
Quantity per Package
20
Contains DI Package
10643351000212
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 |