Duns Number:001660786
Device Description: Softshell Venous Reser. 800ml,Blood Transfer Bag 1000 ml - 2 spike ports,BEQ-RF32 RotaFlow Softshell Venous Reser. 800ml,Blood Transfer Bag 1000 ml - 2 spike ports,BEQ-RF32 RotaFlow,CDI Sat Cell 1/4" System 100,Blood Microfilter System SQ 40 S,Prebypass filter w/o Vent Porous Media 3/8x3/8,Gas Filter
Catalog Number
701050307
Brand Name
Medical City Children's ECC 1/4"
Version/Model Number
BEQ-T 21503
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
DWE
Product Code Name
Tubing, Pump, Cardiopulmonary Bypass
Public Device Record Key
d4287f4f-8724-4905-a5ad-99f9325793a3
Public Version Date
December 02, 2019
Public Version Number
4
DI Record Publish Date
February 13, 2017
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 |