Duns Number:961027315
Device Description: Surgical Respirator, Flat Fold, REG
Catalog Number
USA-N95-R
Brand Name
CARDINAL HEALTH
Version/Model Number
USA-N95-R
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MSH
Product Code Name
Respirator,surgical
Public Device Record Key
ca7d8003-ad8f-4ed6-acb0-a0541d334314
Public Version Date
June 19, 2020
Public Version Number
6
DI Record Publish Date
August 02, 2016
Package DI Number
50885380075184
Quantity per Package
6
Contains DI Package
20885380075183
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |