Duns Number:006261481
Device Description: SURG KIT TK2 BLOOD PROCES W/225BOWL 6PK
Catalog Number
-
Brand Name
NA
Version/Model Number
TK2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K812292,K812292
Product Code
CAC
Product Code Name
APPARATUS, AUTOTRANSFUSION
Public Device Record Key
06ef9589-480e-44a1-9af5-36aa8070be2a
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
June 09, 2015
Package DI Number
20613994520368
Quantity per Package
6
Contains DI Package
00613994520364
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |