INTERNATIONAL BIOPHYSICS CORPORATION

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- Catalog Number : 6000N

Device Description : The IBC FloPump is a single-use, disposable centrifugal blood pump intended for 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6000S

Device Description : The IBC FloPump is a single-use, disposable centrifugal blood pump intended for 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The AffloVest is comprised of a vest of synthetic polymer fabric with oscillatin 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6000S(KIT)

Device Description : The IBC FloPump is a single-use, disposable centrifugal blood pump intended for 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.

Device Class : 2

Duns Number: 788403103

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1