Duns Number:070556204
Device Description: Curaplex Select Endotracheal Tube, 8.5mm, Cuffed, w/o Stylette 10ea/bx 10bx/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
2113-20285
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
fa06d113-210b-48cc-a3b0-3fe3d4e951c6
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
February 06, 2017
Package DI Number
00817617022208
Quantity per Package
10
Contains DI Package
00817617021744
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 |