Duns Number:141668116
Device Description: Basic Chinstrap. One size fits most, cups the chin for comfort, attaches to the top strap Basic Chinstrap. One size fits most, cups the chin for comfort, attaches to the top strap of headgear, works with almost any nasal mask.
Catalog Number
CS002
Brand Name
Basic Chinstrap
Version/Model Number
CS002
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTK
Product Code Name
Strap, Head, Gas Mask
Public Device Record Key
6be8375b-fdf3-48e9-b96e-7024637a387f
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
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 | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |