Duns Number:002065670
Device Description: Jet Ventilator, w/Flow/Trigger Valves, 0-60psi Gauge, O2 DISS Nut 5ft Inlet Hose, LuerM Lo Jet Ventilator, w/Flow/Trigger Valves, 0-60psi Gauge, O2 DISS Nut 5ft Inlet Hose, LuerM Lock 2ft Outlet Hose
Catalog Number
00-325
Brand Name
AincA
Version/Model Number
00-325
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
40f1fa06-d0ab-48c1-a7cc-896c7a142498
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 |