Duns Number:545287658
Device Description: CFM series flowmeter is for medical gas supply system, providing measurement and control f CFM series flowmeter is for medical gas supply system, providing measurement and control for gas supply. It is designed for flow control and monitor on patient's inhalation, and other medical devices' flow control and monitor as well.
Catalog Number
-
Brand Name
GENTEC®
Version/Model Number
CFM-15L
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
98fc2e6d-2267-4679-a52c-406cbd99f99b
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 |