Duns Number:070556204
Device Description: Curaplex Nasopharyngeal Airway, Latex-Free, PVC, 16 FR
Catalog Number
2021-15016
Brand Name
Curaplex
Version/Model Number
2021-15016
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
221b350d-3615-4c02-8920-5449a446f2bd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2017
Package DI Number
00817617026879
Quantity per Package
10
Contains DI Package
00817617026091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |