Duns Number:602759672
Device Description: SAFE-T-FILL® Microhematocrit Capillary Tubes, 68 µL; Plastic, Sodium Heparinized, Red Mark SAFE-T-FILL® Microhematocrit Capillary Tubes, 68 µL; Plastic, Sodium Heparinized, Red Marking
Catalog Number
06 0525
Brand Name
SAFE-T-FILL®
Version/Model Number
06 0525
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
2ddf4c51-a126-4013-b5d5-aea6e0d554ae
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
30643351000377
Quantity per Package
10
Contains DI Package
10643351000373
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |