MPV - MV5001
2025-03-12
Movair, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1645362 | 1000117854 | Movair, Inc. | 1 | Y | 2026-01-01 | 2101 East St. Elmo Rd. Suite 275 Austin TX US 78744 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 75837 | 1854504789 | K983272 | IBC FLOPUMP, MODEL 6000 | KFM | 1999-03-24 |
| 75837 | 1151593205 | K963756 | IBC CARDIAC SUCTION WARD | DTS | 1997-11-14 |
| 75837 | 1128503408 | K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | DPT | 1998-04-08 |
| 75837 | 1638757416 | K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | DWE | 1984-10-19 |
| 75837 | 1998431667 | K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | KFM | 2017-12-15 |
| 75837 | 1652998216 | K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | BYI | 2013-03-27 |
| 75837 | 1239387184 | ||||
| 75837 | 1425765620 | ||||
| 75837 | 1675188667 | ||||
| 75837 | 1970118787 | ||||
| 75837 | 1161131839 |
Product Codes Associated With Registrations#
GUDID#
MPV - MV5000
2025-03-12
"FloProbe 1/4’’ x 1/4"" (Non Sterile)" - The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
2016-07-12
FloProbe 3/8’’ x 3/8” (Non Sterile) - The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
2016-07-12
IBC Aortic Punch, Long, 2.8mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 3.6mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 4.0mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 4.4mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 4.8mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 5.2mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 5.6mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Long, 6.0mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 2.8mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 3.6mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 4.0mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 4.4mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 4.8mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 5.2mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 5.6mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
IBC Aortic Punch, Medium, 6.0mm - The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.
2016-08-02
FloPump - 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.
2021-03-12
FloPump - 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; orii) 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.
2021-03-12
IBC Suction Wand (Non Sterile) - The IBC Suction Wand is a component of Blood Recovery Suction Systems for use in open heart procedures, autologus blood recovery or blood suction. It is a disposable, single use component.
2016-07-11
IBC Mini Sucker (Non Sterile) - The IBC Mini Sucker is a component of Blood Recovery Suction Systems for use in open heart procedures, autologus blood recovery or blood suction. It is a disposable, single use component.
2016-07-11
AffloShield - The AffloShield is a disposable gown intended for use with the AffloVest product line.
2019-12-12
IBC Tubing Organizer (Non Sterile) - The Tubing Organizer is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.
2016-07-15
FloPump - The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
2019-05-09
Stableline Tubing Organizer (Non Sterile) - The Stableline is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.
2016-07-15
FloPump - The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
2015-04-14
FloPump - The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
2015-05-21
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
AffloVest - The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized into zones. The vest may be run on battery or A/C power from a standard wall outlet.The AffloVest is intended for promoting airway clearance and improvement of bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
2015-11-24
FloPump - The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
2015-10-20
FloPump - The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
2015-11-09
FloPump - The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
2015-11-09