Duns Number:080456871
Device Description: Adult Tracheostomy Mask
Catalog Number
001225
Brand Name
Vital Signs™
Version/Model Number
001225
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
BYG
Product Code Name
MASK, OXYGEN
Public Device Record Key
bb4d1e3e-271e-4cd6-95db-170b3f33594b
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 2021
Package DI Number
50190752142044
Quantity per Package
50
Contains DI Package
10190752142046
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |