CARDIOCOMMAND, INC.

Address:4920 WEST CYPRESS STREET,TAMPA,FL,33607,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheter, Electrode Recording, Or Probe, Electrode Recording (DRF) (6) Stethoscope, Esophageal, With Electrical Conductors (BZT) (2) System, Esophageal Pacing (LPA) (2)

Premarket Exempt

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Tapscope - 00856233005004 Catalog Number : 200

Device Description : 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes a 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit package).

Device Class :

Duns Number: 800214827

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Tapscope - 00856233005011 Catalog Number : 250

Device Class :

Duns Number: 800214827

Premarket Exempt : No

Product Code : BZT

Prescription Use : Yes

Device Count : 1

Tapscope - 00856233005028 Catalog Number : 100

Device Description : 10 French esophageal bipolar pacing and recording catheter, (single unit package).

Device Class :

Duns Number: 800214827

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Tapscope - 00856233005035 Catalog Number : 102

Device Description : 10 French esophageal bipolar pacing and recording catheter with a stainless stee 10 French esophageal bipolar pacing and recording catheter with a stainless steel stylet, (single unit package).

Device Class :

Duns Number: 800214827

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Tapcath - 00856233005042 Catalog Number : 180

Device Description : 5 French esophageal bipolar pacing and recording catheter, (single unit package).

Device Class :

Duns Number: 800214827

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Tapcath - 00856233005059 Catalog Number : 1600

Device Description : 6 French esophageal octapolar recording catheter, (single unit package).

Device Class :

Duns Number: 800214827

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Tapsystem - 00856233005066 Catalog Number : 8002A

Device Description : A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit).

Device Class : 3

Duns Number: 800214827

Premarket Exempt : No

Product Code : LPA

Prescription Use : Yes

Device Count : 1

Tapsystem - 00856233005073 Catalog Number : 2010

Device Description : A cable used to connect a patient to a Model 2A pulse generator system for the t A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias.

Device Class : 3

Duns Number: 800214827

Premarket Exempt : No

Product Code : LPA

Prescription Use : Yes

Device Count : 1

EP Connect - 00856233005080 Catalog Number : 8031-0001

Device Description : A 10 ft. cable that connects Tapcath catheter products to ECG recorders using a A 10 ft. cable that connects Tapcath catheter products to ECG recorders using a modular to pin connector. .

Device Class : 2

Duns Number: 800214827

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

EP-Connect - 00856233005097 Catalog Number : 8032

Device Description : A 10 ft. cable that connects Model 1600 Octapolar catheter products to ECG recor A 10 ft. cable that connects Model 1600 Octapolar catheter products to ECG recorders using modular to pin connector.

Device Class : 2

Duns Number: 800214827

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

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