FH Medical Services PASH5-2

GUDID 00852048007127

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

F H MEDICAL SERVICES INC

Electrocardiographic electrode, single-use

• Primary Device ID: 00852048007127
• NIH Device Record Key: c66878f5-4a0b-4555-8917-1b6ba4cbcd69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FH Medical Services
• Version Model Number: PASH5-2
• Catalog Number: PASH5-2
• 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	00852048007127 [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 Services]

• 00852048007172: Holter Kit - 9 packs of 2660-3 3M Electrode
• 00852048007141: Holter Kit - 10 Meditrace 535 electrodes
• 00852048007127: Holter Kit - 1 patient diary, 1 razor, 1 prep pad, 2 alcohol pads, 1 AAA battery, 10 x 455 elect