Duns Number:785952607
Device Description: 22MM CORRUGATED SINGLE PATIENT CIRCUIT W/EXH VALVE 1.6M ELISEE
Catalog Number
-
Brand Name
N/A
Version/Model Number
RM21326
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132143,K132143
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
f01c815c-2d5f-4c62-a840-fc564e916880
Public Version Date
February 07, 2022
Public Version Number
5
DI Record Publish Date
September 17, 2015
Package DI Number
05030267117345
Quantity per Package
25
Contains DI Package
00619498213269
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 |