Duns Number:623191194
Device Description: Health-Tec Earloop Masks, Level 1, Pink
Catalog Number
450-10021
Brand Name
Health-Tec Earloop Masks
Version/Model Number
450-10021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K020474,K020474,K020474
Product Code
MSH
Product Code Name
Respirator,Surgical
Public Device Record Key
9057cd60-4e02-4977-9373-11c18f9cf567
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
January 18, 2017
Package DI Number
D773450100212
Quantity per Package
10
Contains DI Package
D773450100211
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 | 464 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 78 |