Duns Number:079628327
Device Description: Mouthpiece Safe T Shield w/ 22mm adapter & 22mm flexible tubing (extends 6-24 inches)
Catalog Number
-
Brand Name
Insta/Vent - Lung Ventilation Accessories
Version/Model Number
MN0305
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"
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
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
2db5bd15-0573-4f5b-a6f8-05592e84e5c5
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
Package DI Number
00850022357572
Quantity per Package
10
Contains DI Package
00850022357183
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |