Duns Number:961027315
Device Description: N95 RespiratorMedium/Large- Healthcare Particulate Respirator and Surgical Mask- Fluid Res N95 RespiratorMedium/Large- Healthcare Particulate Respirator and Surgical Mask- Fluid Resistant- Meets CDC Guidelines for TB Exposure Control- NIOSH Approved
Catalog Number
N95A-ML
Brand Name
CARDINAL HEALTH
Version/Model Number
N95A-ML
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
e56d025d-ae65-4aa3-9cac-59d6db8511de
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
December 10, 2018
Package DI Number
50885380029293
Quantity per Package
6
Contains DI Package
20885380029292
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 |