AccessGUDID - DEVICE: FloPump (00814321020445)

GUDID

Device Identifier (DI) Information

Brand Name: FloPump
Version or Model: 6500N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6500N
Company Name: Movair, Inc.

Primary DI Number: 00814321020445
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 788403103 *Terms of Use

Device Description: The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31718	Cardiopulmonary bypass system centrifugal pump	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193663	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0174941b-8a7a-4ed1-b957-19f1c31e40d7
Public Version Date: February 24, 2025
Public Version Number: 3
DI Record Publish Date: March 12, 2021