Duns Number:828690904
Device Description: Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece
Catalog Number
1150101
Brand Name
PureLife Dental
Version/Model Number
1150101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
5fd3ee6c-4c21-4b7e-8200-d2f02475ce24
Public Version Date
March 08, 2021
Public Version Number
6
DI Record Publish Date
March 17, 2017
Package DI Number
D79011501013
Quantity per Package
500
Contains DI Package
D79011501011
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 | 4 |