Duns Number:006261481
Device Description: CARTRIDGE 402-02 ACT RACT 13 LAN
Catalog Number
-
Brand Name
RACT
Version/Model Number
402-02
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K853198,K853198
Product Code
JPA
Product Code Name
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Public Device Record Key
75e36e40-31fe-4b3c-93eb-c5961da5df92
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 13, 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 |