Duns Number:068586441
Device Description: Nasal Cannula Adult 7' Straight Tip
Catalog Number
787424
Brand Name
Dealmed
Version/Model Number
787424
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"
Yes
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
CAT
Product Code Name
CANNULA, NASAL, OXYGEN
Public Device Record Key
76826f6f-5416-494e-bc82-f0bb9d54ea25
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
May 19, 2021
Package DI Number
10859140003108
Quantity per Package
50
Contains DI Package
00859140003101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |