Duns Number:830016148
Device Description: 1805 VFLEX HC RESP, SURG MASK 400/C
Catalog Number
1805
Brand Name
VFlex™
Version/Model Number
1805
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
K121069,K121069,K121069
Product Code
MSH
Product Code Name
Respirator,surgical
Public Device Record Key
c41f0728-ff92-4d41-a53d-5dbfaa5ee8bf
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
August 03, 2016
Package DI Number
50051131498551
Quantity per Package
8
Contains DI Package
00051131498556
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |