Duns Number:022721133
Device Description: 2 E-Z Wrap™ Mask Cushions. Soft, closed cell foam cushions designed to prevent ear chafing 2 E-Z Wrap™ Mask Cushions. Soft, closed cell foam cushions designed to prevent ear chafing.
Catalog Number
1017-0-25
Brand Name
N/A
Version/Model Number
1017-0-25
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
-
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
CAT
Product Code Name
CANNULA, NASAL, OXYGEN
Public Device Record Key
1bafe987-493e-45c2-8538-99abcda4fd6b
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
November 30, 2016
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |