Duns Number:141668116
Device Description: Mini CGA 540 Style Regulator 0-4lpm Pediatric (0, 1/32, 1/16, 1/8, 1/4, 1/2, 3/4, 1, 1 1/2 Mini CGA 540 Style Regulator 0-4lpm Pediatric (0, 1/32, 1/16, 1/8, 1/4, 1/2, 3/4, 1, 1 1/2, 2, 3, 4)
Catalog Number
RES047
Brand Name
Mini CGA 540 Style Regulator 0-4lpm Pediatric (0, 1/32, 1/16, 1/8, 1/4, 1/2, 3/4
Version/Model Number
RES047
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
d6d92260-7183-4d74-a07d-6bec8ba43e99
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
10848530081024
Quantity per Package
20
Contains DI Package
00848530081027
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 |