Duns Number:002348191
Device Description: Neoprene Pecan Shaped Breathing Bag with 22 mm neck insert
Catalog Number
20786AP
Brand Name
RUSCH
Version/Model Number
IPN043853
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
97beded4-e895-465f-9595-297c0e0ab786
Public Version Date
October 16, 2018
Public Version Number
1
DI Record Publish Date
September 15, 2018
Package DI Number
24026704552010
Quantity per Package
100
Contains DI Package
04026704552016
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 |