Duns Number:117718048
Device Description: The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face The Savvy Surgical Face Mask is a disposable, single-use surgical mask. The surgical face masks are nonsterile, 3 layers, flat-pleated style. The outer and inner layers of the face masks consist of a thermal bonded bi-component - polyethylene/polyester nonwoven fabric. The middle layer consists of a melt blown polypropylene filter material. Each mask contains ear bands to secure the mask to the user’s face and mouth, as well as a fully enclosed, soft, bendable nosepiece to fit over the nose. This device is not made from natural rubber latex
Catalog Number
-
Brand Name
Savvy Mask® Level 3 Surgical Face Mask
Version/Model Number
SM03
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K213406,K213406
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
24cb3184-cda5-483f-83fd-c5c9b5198ac1
Public Version Date
July 01, 2022
Public Version Number
1
DI Record Publish Date
June 23, 2022
Package DI Number
10850025566169
Quantity per Package
40
Contains DI Package
00850025566162
Package Discontinue Date
June 24, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |