F H MEDICAL SERVICES INC

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Filters

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

Electrode, Electrocardiograph (DRX) (10)

Premarket Exempt

No Yes

Clear

Stable Base - 00852048007110 Catalog Number : FHM255AC

Device Description : Holter Kit - 1 pack of 7 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pa Holter Kit - 1 pack of 7 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pads, 1 razor, 7 strip tapes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FH Medical Services - 00852048007127 Catalog Number : PASH5-2

Device Description : Holter Kit - 1 patient diary, 1 razor, 1 prep pad, 2 alcohol pads, 1 AAA battery Holter Kit - 1 patient diary, 1 razor, 1 prep pad, 2 alcohol pads, 1 AAA battery, 10 x 455 electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stablebase - 00852048007134 Catalog Number :

Device Description : Holter kit - 1 patient diary, 1 AA battery, 2 alcohol pads, 5 lead lok electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FH Medical Services - 00852048007141 Catalog Number :

Device Description : Holter Kit - 10 Meditrace 535 electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007158 Catalog Number :

Device Description : Holter Kit - 1 patient diary, 1 AA battery, 1 prep pad, 1 razor, 2 alcohol pads, Holter Kit - 1 patient diary, 1 AA battery, 1 prep pad, 1 razor, 2 alcohol pads, 7 lead lok electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FH Medical - 00852048007165 Catalog Number :

Device Description : Holter Kit - 5 packs of Medi-Trace 455 electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FH Medical Services - 00852048007172 Catalog Number :

Device Description : Holter Kit - 9 packs of 2660-3 3M Electrode

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007189 Catalog Number :

Device Description : 1 patient diary, 10 stable base cloth electrodes, 1 aa battery, 1 razor, 2 alcoh 1 patient diary, 10 stable base cloth electrodes, 1 aa battery, 1 razor, 2 alcohol pads, 5 strip tapes, 1 unisolve wipe

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007196 Catalog Number :

Device Description : Holter Kit - 1 patient diary, 1 AA battery, 1 razor, 1 prep pad, 2 alcohol pads, Holter Kit - 1 patient diary, 1 AA battery, 1 razor, 1 prep pad, 2 alcohol pads, 5 lead lok electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00861779000284 Catalog Number : FHM221

Device Description : 1 patient diary, 1 4x4 gauze, 2 AAA batteries, 1 razor, 2 alcohol pads, 5 lead l 1 patient diary, 1 4x4 gauze, 2 AAA batteries, 1 razor, 2 alcohol pads, 5 lead lok electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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