Duns Number:006261481
Device Description: DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM
Catalog Number
-
Brand Name
HEPtrac®
Version/Model Number
313-51
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
K981815
Product Code
JPA
Product Code Name
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Public Device Record Key
74190b82-e470-495c-89e8-d5d73a92687d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 04, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |