Duns Number:200103823
Device Description: Blue RUSCH branded infant manual resuscitator, oxygen reservoir tubing, swivel connector, Blue RUSCH branded infant manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and infant mask.
Catalog Number
157400300
Brand Name
RUSCH
Version/Model Number
157400300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 16, 2020
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
K993194,K993194
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
5673ddfd-ccb9-4a54-84e9-68fef629f20b
Public Version Date
January 17, 2020
Public Version Number
4
DI Record Publish Date
August 24, 2015
Package DI Number
10627843557576
Quantity per Package
6
Contains DI Package
00627843557579
Package Discontinue Date
January 16, 2020
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |