Duns Number:051624070
Device Description: Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control. Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.)
Catalog Number
745X
Brand Name
Lyphochek
Version/Model Number
745X
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
K012722
Product Code
GGN
Product Code Name
PLASMA, COAGULATION CONTROL
Public Device Record Key
b79fbcba-aa5d-4cbc-b6b8-5e8921e9c0b5
Public Version Date
July 29, 2021
Public Version Number
5
DI Record Publish Date
September 12, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |