Duns Number:506692297
Device Description: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory
Catalog Number
201001
Brand Name
ROTEM®
Version/Model Number
delta System (US/CA)
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083842
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
23ee333b-eea7-480b-bc7f-1d4a5654d998
Public Version Date
February 03, 2020
Public Version Number
3
DI Record Publish Date
March 15, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |