Duns Number:198013435
Device Description: Anchor, Support, Organizer (Qty 25)NeoHug Smiley Blue - Suction (Qty. 5)NeoHug Smiley Brig Anchor, Support, Organizer (Qty 25)NeoHug Smiley Blue - Suction (Qty. 5)NeoHug Smiley Bright Pink - Suction (Qty. 5)NeoHug Smiley Green - Suction (Qty. 5)NeoHug Smiley Violet - Suction (Qty. 5)NeoHug Smiley Bright Orange - Suction (Qty. 5)
Catalog Number
N681A-S
Brand Name
NeoHug Smiley Assorted -Suction
Version/Model Number
00812594013409
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
c2d1512b-a343-4b7a-bf1c-5c62874d7546
Public Version Date
July 26, 2022
Public Version Number
2
DI Record Publish Date
June 14, 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 |