Duns Number:023904428
Device Description: Tracheostomy Mask ADULT MULTIDIRECTIONAL SWIVEL SINGLE PATIENT USE
Catalog Number
-
Brand Name
McKesson
Version/Model Number
32635
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
00c2b9bb-32a5-47b7-b083-a81235ed48d8
Public Version Date
July 29, 2020
Public Version Number
1
DI Record Publish Date
July 21, 2020
Package DI Number
40612479208375
Quantity per Package
50
Contains DI Package
20612479208364
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |