Duns Number:141668116
Device Description: Universal Headgear. One size fits most, can be used with most 4-point nasal or full face C Universal Headgear. One size fits most, can be used with most 4-point nasal or full face CPAP masks.
Catalog Number
HG003
Brand Name
Universal Headgear
Version/Model Number
HG003
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
fde513e8-1e87-49e0-8270-c7241cb5c7cc
Public Version Date
August 29, 2018
Public Version Number
1
DI Record Publish Date
July 29, 2018
Package DI Number
10848530080225
Quantity per Package
200
Contains DI Package
00848530080228
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 |