Duns Number:092673953
Device Description: Pediatric Venturi Mask w/ Diluters, Aerosol Tubing/Hood, 8' oxygen tubing and TN
Catalog Number
-
Brand Name
Pediatric Elongated Venturi Mask Kit
Version/Model Number
3227-E
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
BYF
Product Code Name
Mask, Oxygen, Low Concentration, Venturi
Public Device Record Key
69466446-be5e-4eea-9e7b-15f83e2a5272
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2017
Package DI Number
10709078004633
Quantity per Package
50
Contains DI Package
00709078004636
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |