Duns Number:014578892
Device Description: N95 SURGICAL RESPIRATOR MASK 2CT
Catalog Number
-
Brand Name
RITE AID PHARMACY
Version/Model Number
F405-604RA
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"
-
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
b64a941b-fe42-4510-9356-453f3af8d2c8
Public Version Date
February 24, 2021
Public Version Number
1
DI Record Publish Date
February 16, 2021
Package DI Number
20011822257156
Quantity per Package
4
Contains DI Package
00011822257152
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
U | Unclassified | 2 |