Duns Number:070698154
Catalog Number
-
Brand Name
HemoTemp II
Version/Model Number
3000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 12, 2022
Issuing Agency
In HIBCC
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
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
d717e357-47c5-492c-94b2-41c2e048f30e
Public Version Date
February 14, 2022
Public Version Number
6
DI Record Publish Date
February 08, 2017
Package DI Number
M74430002
Quantity per Package
5
Contains DI Package
M74430001
Package Discontinue Date
February 12, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |