Duns Number:152578522
Device Description: A blood bag temperature monitor for use by health care providers to determine if blood or A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Catalog Number
7201-50
Brand Name
Safe-T-Vue 10
Version/Model Number
STV10
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK910005,BK910005,BK910005
Product Code
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
c955e39b-88e2-4eb0-9216-7c2092225291
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
20852282007147
Quantity per Package
4
Contains DI Package
10852282007140
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 200
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |