Duns Number:002348191
Device Description: Neoprene Pecan Shaped Bag with 19 mm cuff
Catalog Number
20791AP
Brand Name
RUSCH
Version/Model Number
IPN913343
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
-
Product Code
BTC
Product Code Name
BAG, RESERVOIR
Public Device Record Key
93ff1bf5-5881-4adc-88ae-49e9da5558ce
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
Package DI Number
34026704640554
Quantity per Package
100
Contains DI Package
14026704640550
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |