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

F H Medical Services - 00852048007011 Catalog Number : FH005

Device Description : 1 pack of 5 electrodes, 1 AAA battery, 1 patient diary, 2 alcohol pads, 1 abras 1 pack of 5 electrodes, 1 AAA battery, 1 patient diary, 2 alcohol pads, 1 abrasive prep pad

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

F H Medical Services - 00852048007028 Catalog Number : FH006

Device Description : 1 pack of 5 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pads, 1 abrasi 1 pack of 5 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pads, 1 abrasive prep pad

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007035 Catalog Number : CMC196

Device Description : CMC 196 includes 1 patient diary, 4 alcohol prep pads, 1 prep pad, 1 AAA battery CMC 196 includes 1 patient diary, 4 alcohol prep pads, 1 prep pad, 1 AAA battery, and 1 pack of 7 lead lok electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007042 Catalog Number : FHM162

Device Description : Holter Kit - 1 patient diary, 1 prep pad, 1 pack of 5 lead lok electrodes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007059 Catalog Number : RZ153+KC (AAA)

Device Description : Holter Kit - 1 patient diary, 1 AAA battery, 1 razor, 2 alcohol pads, 7 lead lok Holter Kit - 1 patient diary, 1 AAA battery, 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

Stable Base - 00852048007066 Catalog Number : RZ153+5KC (AAA)

Device Description : Holter Kit - 1 patient diary, 1 AAA battery, 1 razor, 2 alcohol pads, 5 lead lok Holter Kit - 1 patient diary, 1 AAA battery, 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

Stable Base - 00852048007073 Catalog Number :

Device Description : Holter Kit - 1 patient diary, 7 lead lok electrodes, 1 AA battery, 1 razor, 5 st Holter Kit - 1 patient diary, 7 lead lok electrodes, 1 AA battery, 1 razor, 5 strip n tapes

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FH Medicals Services - 00852048007080 Catalog Number :

Device Description : Holter Kit - 5 packs of Medi-Trace 535 Electrode

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Stable Base - 00852048007097 Catalog Number :

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

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

FH Medical - 00852048007103 Catalog Number :

Device Description : Holter Kit - 5 x 455 electrodes, 1 patient diary, 2 alcohol pads, 1 prep pad, 1 Holter Kit - 5 x 455 electrodes, 1 patient diary, 2 alcohol pads, 1 prep pad, 1 razor, 1 AAA battery

Device Class : 2

Duns Number: 063505010

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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