Duns Number:079899693
Device Description: COREVENTThe Peerbridge Cor™ System is a family of products comprised of two models, thePee
Catalog Number
COREVENT
Brand Name
Peerbridge Cor System
Version/Model Number
COREVENT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
-
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
K171936,K171936
Product Code
DSH
Product Code Name
Recorder, Magnetic Tape, Medical
Public Device Record Key
b51899e2-e359-490f-bd1e-8a4d02d38eac
Public Version Date
July 04, 2022
Public Version Number
8
DI Record Publish Date
February 06, 2018
Package DI Number
B608COREVENT1
Quantity per Package
5
Contains DI Package
B608COREVENT0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |