Duns Number:961027315
Device Description: Nasopharyngeal Airway - Adjustable Flange, 14Fr/I.D.3.0mm
Catalog Number
ADJ14FR
Brand Name
CARDINAL HEALTH
Version/Model Number
ADJ14FR
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
BTQ
Product Code Name
AIRWAY, NASOPHARYNGEAL
Public Device Record Key
5a4c99ca-4080-475c-99bb-56c60cca533f
Public Version Date
July 19, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
20885380010146
Quantity per Package
10
Contains DI Package
00885380010142
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |