Duns Number:122314606
Device Description: Single Pack Nosebleed Tourniquet Device - Small
Catalog Number
01-PN-014
Brand Name
Nose It All
Version/Model Number
01-PN-014
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMX
Product Code Name
Balloon, Epistaxis
Public Device Record Key
84cae411-4473-42f0-82cf-d408398cf67f
Public Version Date
April 13, 2022
Public Version Number
1
DI Record Publish Date
April 05, 2022
Package DI Number
00860006794736
Quantity per Package
3
Contains DI Package
00860006794705
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 | 1 |