Duns Number:867673159
Device Description: RespiratoryRespiratory Disposables Product Description: Pedi Non-Rebreathing Mask50/CS
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
MASK 009P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2018
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"
-
For Single-Use
-
Prescription Use (Rx)
-
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
b4424230-d9de-45ce-88cc-10b63d33354b
Public Version Date
July 16, 2019
Public Version Number
4
DI Record Publish Date
May 19, 2017
Package DI Number
00822383132341
Quantity per Package
50
Contains DI Package
50822383132346
Package Discontinue Date
March 08, 2018
Package Status
Not 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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |