Duns Number:557223252
Device Description: HemosIL Apixaban Controls kit consists of:1. Apixaban Low Control (Cat. No. 0020015310): 5 HemosIL Apixaban Controls kit consists of:1. Apixaban Low Control (Cat. No. 0020015310): 5 x 1 mL vials 2. Apixaban High Control (Cat. No. 0020015320): 5 x 1 mL vials
Catalog Number
00020015300
Brand Name
HemosIL Apixaban Controls
Version/Model Number
0020015300
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
8c327363-5860-4d96-91ad-fba2a4c62c2e
Public Version Date
September 30, 2021
Public Version Number
4
DI Record Publish Date
April 16, 2021
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 272 |