Duns Number:025460908
Device Description: MASK,ANESTH,INFANT,SZ 2,TOP VALVE,BGUM
Catalog Number
DYNJAAMASK32B
Brand Name
Medline
Version/Model Number
DYNJAAMASK32B
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
a8d75a07-e9d0-4912-93f3-38fdb9c6475f
Public Version Date
July 05, 2021
Public Version Number
1
DI Record Publish Date
June 25, 2021
Package DI Number
20888277420486
Quantity per Package
50
Contains DI Package
10888277420489
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 |