Duns Number:002065670
Device Description: Jet Ventilator Replacement Hose, MRI, Special, Outlet, See LotNumber for Custom Hose Info
Catalog Number
00-325-MRI-LP-S
Brand Name
AincA
Version/Model Number
00-325-MRI-LP-S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
-
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
K921926
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
76754c69-c9d4-4e90-bb1f-967ccfeae108
Public Version Date
September 25, 2020
Public Version Number
5
DI Record Publish Date
August 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 561 |
2 | A medical device with a moderate to high risk that requires special controls. | 135 |