FloPump 6500N
GUDID 00814321020445
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.
INTERNATIONAL BIOPHYSICS CORPORATION
Cardiopulmonary bypass system centrifugal pump| Primary Device ID | 00814321020445 |
| NIH Device Record Key | 0174941b-8a7a-4ed1-b957-19f1c31e40d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FloPump |
| Version Model Number | 6500N |
| Catalog Number | 6500N |
| Company DUNS | 788403103 |
| Company Name | INTERNATIONAL BIOPHYSICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814321020445 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193663
FDA Product Code
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
[00814321020445]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
On-Brand Devices [FloPump]
| 00814321020148 | The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to |
| 00814321020131 | The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to |
| 00814321020124 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020117 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020100 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020094 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020018 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020001 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020452 | The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with th |
| 00814321020445 | The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to |
| 00814321020438 | The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to |
Trademark Results [FloPump]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLOPUMP 87341909 5321566 Live/Registered |
International Biophysics Corporation 2017-02-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.