Duns Number:938289980
Device Description: A collection of sterile devices intended to be used to inject cardioplegia solution into t A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.
Catalog Number
H-1136
Brand Name
STANDARD VAVD KIT
Version/Model Number
H-1136
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K990514,K990514
Product Code
DTP
Product Code Name
Defoamer, Cardiopulmonary Bypass
Public Device Record Key
b75084fa-1ccc-4e18-b258-6149fefc6c3d
Public Version Date
March 10, 2022
Public Version Number
5
DI Record Publish Date
September 26, 2016
Package DI Number
B066H11366
Quantity per Package
10
Contains DI Package
B066H11360
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |