Duns Number:092673953
Device Description: Adult CO2/O2 Mask, 10'x 0.50 GLS w Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' O Adult CO2/O2 Mask, 10'x 0.50 GLS w Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter
Catalog Number
-
Brand Name
Adult CO2 /O2 Mask
Version/Model Number
0562F
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
c447e4d5-3b0a-4e54-a424-584f8e07b04f
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
May 16, 2018
Package DI Number
10709078005661
Quantity per Package
50
Contains DI Package
00709078005664
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |