Duns Number:009299017
Device Description: UNIVERSAL FLEX2 CIRCUIT 50/CS
Catalog Number
DFP275V-6121
Brand Name
UNIVERSAL FLEX2®BREATHING CIRCUIT
Version/Model Number
DFP275V-6121
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAI
Product Code Name
Circuit, breathing (w connector, adaptor, y piece)
Public Device Record Key
739fcb54-e68b-4b3d-88bb-08b9761bd72b
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
00612649183800
Quantity per Package
50
Contains DI Package
00612649202501
Package Discontinue Date
June 21, 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 | 717 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |