FH Medical

GUDID 00852048007103

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

F H MEDICAL SERVICES INC

Electrocardiographic electrode, single-use

• Primary Device ID: 00852048007103
• NIH Device Record Key: 71d4808f-a612-4f6a-9f3d-51db65c03fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FH Medical
• Version Model Number: PASH5
• 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	00852048007103 [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: 2016-11-30

On-Brand Devices [FH Medical]

• 00852048007165: Holter Kit - 5 packs of Medi-Trace 455 electrodes
• 00852048007103: Holter Kit - 5 x 455 electrodes, 1 patient diary, 2 alcohol pads, 1 prep pad, 1 razor, 1 AAA bat