Duns Number:010712461
Device Description: Valved Tee Adapter, VibraPEP, 22mm OD x 18 mm ID, 22 mm ID side port
Catalog Number
301-12218
Brand Name
Curaplex
Version/Model Number
301-12218
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)
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
a3e40e26-b1d4-48de-919e-a2ddfc8d1aeb
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
April 18, 2017
Package DI Number
00818834020398
Quantity per Package
120
Contains DI Package
00818834020374
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 | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |