Duns Number:043833813
Device Description: KIT, CONVENIENCE, VENTI-PAK FOR VENTI SCAN (ADAPTER KIT FOR VENTILATOR ASSISTED PATIENTS
Catalog Number
177-075
Brand Name
VENTI-SCAN IV
Version/Model Number
177-075
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K871868,K871868,K871868,K871868
Product Code
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
50dbfc34-d7b9-4dee-bc9e-0638d07d9df7
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2019
Package DI Number
30718175005157
Quantity per Package
15
Contains DI Package
00718175005156
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 193 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |