FH Medicals Services

GUDID 00852048007080

Holter Kit - 5 packs of Medi-Trace 535 Electrode

F H MEDICAL SERVICES INC

Electrocardiographic electrode, single-use

• Primary Device ID: 00852048007080
• NIH Device Record Key: f7e792c2-4a82-41f7-94d7-c8b5dd6d164a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FH Medicals Services
• Version Model Number: VBI5
• Company DUNS: 063505010
• Company Name: F H MEDICAL SERVICES INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852048007080 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-10

Devices Manufactured by F H MEDICAL SERVICES INC

• 00852048007011 - F H Medical Services: 2018-03-29 1 pack of 5 electrodes, 1 AAA battery, 1 patient diary, 2 alcohol pads, 1 abrasive prep pad
• 00852048007028 - F H Medical Services: 2018-03-29 1 pack of 5 electrodes, 1 AA battery, 1 patient diary, 2 alcohol pads, 1 abrasive prep pad
• 00852048007035 - Stable Base: 2018-03-29 CMC 196 includes 1 patient diary, 4 alcohol prep pads, 1 prep pad, 1 AAA battery, and 1 pack of 7 lead lok electrodes
• 00852048007042 - Stable Base: 2018-03-29 Holter Kit - 1 patient diary, 1 prep pad, 1 pack of 5 lead lok electrodes
• 00852048007059 - Stable Base: 2018-03-29 Holter Kit - 1 patient diary, 1 AAA battery, 1 razor, 2 alcohol pads, 7 lead lok electrodes
• 00852048007066 - Stable Base: 2018-03-29 Holter Kit - 1 patient diary, 1 AAA battery, 1 razor, 2 alcohol pads, 5 lead lok electrodes
• 00852048007073 - Stable Base: 2018-03-29 Holter Kit - 1 patient diary, 7 lead lok electrodes, 1 AA battery, 1 razor, 5 strip n tapes
• 00852048007080 - FH Medicals Services: 2018-03-29Holter Kit - 5 packs of Medi-Trace 535 Electrode
• 00852048007080 - FH Medicals Services: 2018-03-29 Holter Kit - 5 packs of Medi-Trace 535 Electrode