Duns Number:025460908
Device Description: MASK,FLEXIBLE,ANESTH,SIZE 2,TOP VALVE
Catalog Number
DYNJAAMASK32
Brand Name
Medline
Version/Model Number
DYNJAAMASK32
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
a568b11d-a71c-45a6-9b37-88a0c1af4b64
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 03, 2021
Package DI Number
20888277407890
Quantity per Package
50
Contains DI Package
10888277407893
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |