Duns Number:057827420
Device Description: RBC BAG WITH LUER LOCK, 600ML
Catalog Number
-
Brand Name
HAEMONETICS CELL SAVER SYSTEMS
Version/Model Number
00165-00
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
-
Product Code
CAC
Product Code Name
APPARATUS, AUTOTRANSFUSION
Public Device Record Key
58c76d5a-55b3-4ab8-a36c-48fcf26edffa
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2017
Package DI Number
30812747016005
Quantity per Package
4
Contains DI Package
20812747016008
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 |