Duns Number:002348191
Device Description: Face mask for anesthesia, pediatric
Catalog Number
154300-000030
Brand Name
RUSCH
Version/Model Number
IPN042563
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"
-
For Single-Use
-
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
BSJ
Product Code Name
MASK, GAS, ANESTHETIC
Public Device Record Key
ae25a573-1ef1-4cbc-8f2e-7a50ae428282
Public Version Date
October 16, 2018
Public Version Number
1
DI Record Publish Date
September 15, 2018
Package DI Number
44026704017834
Quantity per Package
100
Contains DI Package
24026704017830
Package Discontinue Date
-
Package Status
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 | 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 |