Duns Number:079628327
Device Description: Face Mask, Pediatric (size 2), Air-Cushioned, 22mm ID
Catalog Number
-
Brand Name
Healthline
Version/Model Number
MN4046
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
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
944a92fc-5d11-45d6-9659-c4be1c203ca0
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
June 09, 2017
Package DI Number
00857863007642
Quantity per Package
20
Contains DI Package
00857863007567
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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. | 90 |