Duns Number:057827420
Device Description: QC LEVEL 2
Catalog Number
-
Brand Name
TEG6s HEMOSTASIS SYSTEM
Version/Model Number
07-651-US
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
K140893,K140893
Product Code
JOZ
Product Code Name
SYSTEM, AUTOMATED PLATELET AGGREGATION
Public Device Record Key
fe2947b9-43f2-4fff-b660-7c385b47b42a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 2017
Package DI Number
20812747018309
Quantity per Package
10
Contains DI Package
10812747018302
Package Discontinue Date
-
Package Status
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |