Duns Number:141668116
Device Description: Universal Neoprene Chinstrap. Can be used with any nasal mask or nasal pillows, one size f Universal Neoprene Chinstrap. Can be used with any nasal mask or nasal pillows, one size fits most.
Catalog Number
CS001
Brand Name
Universal Neoprene Chinstrap
Version/Model Number
CS001
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
9ef424e3-289c-46e8-9850-d064b791267f
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
Package DI Number
10848530080010
Quantity per Package
250
Contains DI Package
00848530080013
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 | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |