Duns Number:368457563
Device Description: Patient Breathing Circuit for iVent™ 201, 4 m/ 13 ft, Disposable
Catalog Number
M1162030
Brand Name
N/A
Version/Model Number
M1162030
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
1c1ed2ef-7cdb-480b-a6b3-e06220204c23
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
January 29, 2021
Package DI Number
20190752125718
Quantity per Package
12
Contains DI Package
10190752125711
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |