Duns Number:545287658
Device Description: 286M Series medical regulator is an active medical device and pressure -reducing devices t 286M Series medical regulator is an active medical device and pressure -reducing devices that lower the high-pressure oxygen within a cylinder to a safe usable level.
Catalog Number
-
Brand Name
GENTEC®
Version/Model Number
286MB-25L2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 09, 2031
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAN
Product Code Name
Regulator, Pressure, Gas Cylinder
Public Device Record Key
21924dd9-c8d1-47e6-8d18-b701b4edd3c4
Public Version Date
November 17, 2021
Public Version Number
1
DI Record Publish Date
November 09, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |