Duns Number:198013435
Device Description: Nasal Seal CPAP (Qty. 150)
Catalog Number
N420
Brand Name
NeoSeal Micro
Version/Model Number
10812594012164
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BXJ
Product Code Name
Clip, Nose
Public Device Record Key
960df08c-5b75-43f9-880b-1e20e36e612e
Public Version Date
July 26, 2022
Public Version Number
3
DI Record Publish Date
May 19, 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 |