Duns Number:368457563
Device Description: MRI Extension Tubing Set-Patient Breathing Circuit for iVent™ 201
Catalog Number
M1162025
Brand Name
N/A
Version/Model Number
M1162025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
15c72e31-7a9f-4f7c-858b-3d94b1c1cc75
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
January 28, 2021
Package DI Number
50190752160437
Quantity per Package
20
Contains DI Package
10190752160439
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 |