Duns Number:002348191
Device Description: Manual Pulmonary Resuscitator With Oxygen reservior tubing, swivel connector, medication P Manual Pulmonary Resuscitator With Oxygen reservior tubing, swivel connector, medication Port, Peep connector and Small mask
Catalog Number
157300300
Brand Name
RUSCH
Version/Model Number
IPN914334
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
K993194,K993194
Product Code
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
754a80db-10b9-41b5-9fb2-5dc1f0d6a2c7
Public Version Date
January 20, 2021
Public Version Number
3
DI Record Publish Date
June 10, 2019
Package DI Number
24026704645675
Quantity per Package
6
Contains DI Package
14026704645678
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 |