Duns Number:785952607
Device Description: 15MM S/BORE DOUBLE PATIENT CIRCUIT W/TRAPS 1.6M
Catalog Number
-
Brand Name
N/A
Version/Model Number
RM21302
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
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
6bab49cd-339d-43f0-9109-9ccafc34d1de
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
05030267114542
Quantity per Package
12
Contains DI Package
00619498213023
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |