Duns Number:316403245
Device Description: Hematocrit capillaries
Catalog Number
2074
Brand Name
Hematocrit capillaries
Version/Model Number
2074
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 05, 2020
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)
Yes
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
31f498bd-a8c5-4d5e-b4a5-c0c048ffbc78
Public Version Date
February 11, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
04050674019279
Quantity per Package
10
Contains DI Package
04050674084833
Package Discontinue Date
February 05, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 201 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |