Duns Number:057827420
Device Description: LipiGuard SB Reinfusion Filter for Salvaged Blood
Catalog Number
-
Brand Name
LipiGuard SB
Version/Model Number
SB1E
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"
Yes
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
K960993,K960993
Product Code
CAK
Product Code Name
Microfilter, blood transfusion
Public Device Record Key
32780eed-751b-4321-ae35-fd5a42dcce5e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 19, 2017
Package DI Number
30887691001247
Quantity per Package
40
Contains DI Package
10887691001243
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |