Duns Number:134472476
Device Description: AAMI LEVEL 1, PROCEDURE MASK, EARLOOP, GREEN, NON STERILE, UNIVERSAL SIZE
Catalog Number
382966
Brand Name
Regard
Version/Model Number
A1PMSKELUL-REG
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031353,K160269,K031353,K160269
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
cf836dca-76c6-4443-9156-5aa6370c6d38
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
March 23, 2020
Package DI Number
10326053117616
Quantity per Package
1000
Contains DI Package
00326053117619
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 558 |