Duns Number:043833813
Device Description: AIR CUSHIONED FACE MASK AND DIRECT DOSE ADMINISTRATION ADAPTER -INCLUDES BACTERIA FILTER A AIR CUSHIONED FACE MASK AND DIRECT DOSE ADMINISTRATION ADAPTER -INCLUDES BACTERIA FILTER AND ULTRA-FLEX TUBING
Catalog Number
134-772
Brand Name
XENON CONVENIENCE KITS
Version/Model Number
134-772
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
-
Product Code
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
a05b94b2-d5e9-48a3-bbd8-0c8ca6b9e2f0
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2019
Package DI Number
10718175005245
Quantity per Package
25
Contains DI Package
00718175005248
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 |