Duns Number:070556204
Device Description: Curaplex Nasopharyngeal Airway Kit incl 6 Airways - 20 Fr - 24 Fr - 28 Fr- 30 Fr - 32 Fr a Curaplex Nasopharyngeal Airway Kit incl 6 Airways - 20 Fr - 24 Fr - 28 Fr- 30 Fr - 32 Fr and 34 Fr
Catalog Number
021169-1S
Brand Name
Curaplex
Version/Model Number
021169-1S
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)
-
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
a2636e48-f5e0-4c9b-bed4-1cd0cf94763b
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
December 15, 2018
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 | 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 |