Duns Number:658023890
Device Description: ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are in ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The face masks are single use, disposable device, provided non-sterile.
Catalog Number
-
Brand Name
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask
Version/Model Number
FM-140G
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)
Yes
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
81c522f1-2b22-4b24-9bc7-c355b7859097
Public Version Date
March 31, 2022
Public Version Number
1
DI Record Publish Date
March 23, 2022
Package DI Number
14710415360042
Quantity per Package
40
Contains DI Package
04710415360045
Package Discontinue Date
-
Package Status
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. | 28 |