Duns Number:002065670
Device Description: Mask, Face, Clear Silicone, Flap Seal, 22mmF w/Hook Ring, Size 5 Large Adult, Silicone/Pol Mask, Face, Clear Silicone, Flap Seal, 22mmF w/Hook Ring, Size 5 Large Adult, Silicone/Polycarbonate
Catalog Number
LF-136-5
Brand Name
AincA®
Version/Model Number
LF-136-5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
MASK, GAS, ANESTHETIC
Public Device Record Key
3079eadc-bf5b-4f70-a39e-50331591ba49
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 561 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |