Duns Number:557223252
Device Description: 1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL2. Level 2 D-D Control(Cat. No. 1. Level 1 D-D Control(Cat. No. 0022660031): 5 vials x 1 mL2. Level 2 D-D Control(Cat. No. 0022660032): 5 vials x 1 mL
Catalog Number
00022660030
Brand Name
HemosIL D-Dimer Controls
Version/Model Number
0022660030
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
72e7799c-6fab-4e67-bf6c-7695545e9abe
Public Version Date
August 23, 2021
Public Version Number
1
DI Record Publish Date
August 15, 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 |