Duns Number:141668116
Device Description: Mini CGA 540 Style Regulator- 0-8 lpm
Catalog Number
RES044
Brand Name
Mini CGA 540 Style Regulator- 0-8 lpm
Version/Model Number
RES044
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"
-
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
CAN
Product Code Name
Regulator, Pressure, Gas Cylinder
Public Device Record Key
8cb6d91c-8ef2-4150-8bc0-31df07575fbf
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
September 17, 2018
Package DI Number
10848530060708
Quantity per Package
20
Contains DI Package
00848530060701
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |