Model: CP37V-V0
DI: 18051160300614
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
497c6723-6b61-4b6d-a300-6ca957b6ab21
Distribution Status:
In Commercial Distribution
DUNS Number:
436188505
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
18051160300614
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 31718
Name: Cardiopulmonary bypass system centrifugal pump
Definition:
A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.
FDA Product Codes
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Premarket Submissions
Item #1 - Submission Number:
K192850
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K202169
Item #2 - Supplement Number:
000