Duns Number:315654579
Device Description: Waste bag, 10 Liter, is a replacement waste bag to be used with the AT1 Autotransfusion se Waste bag, 10 Liter, is a replacement waste bag to be used with the AT1 Autotransfusion set.
Catalog Number
9006284
Brand Name
Waste bag 10 l
Version/Model Number
9006284
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
GKT
Product Code Name
Separator, Automated, Blood Cell, Diagnostic
Public Device Record Key
d1162379-8dda-4866-81c8-92627ed1b5cf
Public Version Date
March 30, 2021
Public Version Number
6
DI Record Publish Date
November 10, 2015
Package DI Number
04052682000539
Quantity per Package
5
Contains DI Package
04052682000522
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |