Duns Number:198013435
Device Description: Headrail Adapter, Organizer (Qty 25)Blue - Qty 5Orange - Qty. 5Bright Pink - Qty. 5Green - Headrail Adapter, Organizer (Qty 25)Blue - Qty 5Orange - Qty. 5Bright Pink - Qty. 5Green - Qty 5Violet - Qty 5"
Catalog Number
N680A-H
Brand Name
NeoHug Assorted - Headrail
Version/Model Number
00812594013362
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
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
-
Product Code
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
0e0c246a-d19b-4f46-bde6-b90ff72620f5
Public Version Date
July 26, 2022
Public Version Number
2
DI Record Publish Date
June 15, 2021
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 | 153 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |