Duns Number:010712461
Device Description: TEE,VALVED,ADL,22MM OD/ID,DISP,30/BX,12BX/ CA
Catalog Number
301-T101
Brand Name
Curaplex
Version/Model Number
301-T101
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
BZO
Product Code Name
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Public Device Record Key
ebb4b35c-8870-4793-a0cb-aedd6f399324
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
June 20, 2017
Package DI Number
00812574029956
Quantity per Package
30
Contains DI Package
00812574029949
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |