Duns Number:002348191
Device Description: Neoprene Pecan Shaped Breathing Bag with 22 mm neck insert
Catalog Number
22170A
Brand Name
RUSCH
Version/Model Number
IPN044012
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
ca0ec272-8498-439a-9770-490d1a8fec9c
Public Version Date
January 23, 2020
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
24026704552119
Quantity per Package
100
Contains DI Package
04026704552115
Package Discontinue Date
September 30, 2019
Package Status
Not 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 |