Duns Number:092673953
Device Description: Comfort Soft Plus CO2/O2 Adult Mask, 10' x .050 GSL w/ Swivel Elbow, 2' pigtail w/Female L Comfort Soft Plus CO2/O2 Adult Mask, 10' x .050 GSL w/ Swivel Elbow, 2' pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Filter and Adapter
Catalog Number
-
Brand Name
Comfort Soft Plus
Version/Model Number
0562-02
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
K922492
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
50d5a31c-927d-461d-af58-c58079270c5d
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |