Duns Number:001660786
Device Description: BEQ-HMOD 70000-USA Adult Quadrox iD,BO-VHK 31000 Venous Res. Pediatric (MACE),BEQ-RF32 Rot BEQ-HMOD 70000-USA Adult Quadrox iD,BO-VHK 31000 Venous Res. Pediatric (MACE),BEQ-RF32 RotaFlow,HPH 400,SAT/CRIT conn 3/8",
Catalog Number
701065426R01
Brand Name
CHKD All-in-One Pack
Version/Model Number
BEQ-TOP 31602
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2018
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
DWE
Product Code Name
Tubing, Pump, Cardiopulmonary Bypass
Public Device Record Key
a4245dd4-d203-4e6f-9805-449f4ca7b3cf
Public Version Date
December 02, 2019
Public Version Number
5
DI Record Publish Date
July 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 663 |