Duns Number:070556204
Device Description: Curaplex Endotracheal Tube with Stylette, 7.5mm, Cuffed 10ea/bx 10bx/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
38016
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
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
b51fdcff-5628-4d27-a8f2-31e1f0c933d8
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
December 14, 2016
Package DI Number
00815277027038
Quantity per Package
10
Contains DI Package
00815277027021
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 | 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 |