Holter Monitor 1

GUDID 00860002827308

Holter Monitor

MEMTEC CORPORATION

Electrocardiographic long-term ambulatory recording analyser

• Primary Device ID: 00860002827308
• NIH Device Record Key: cb54d5d0-a772-4a13-9e03-411a7b0cb6ff
• Commercial Distribution Discontinuation: 2029-11-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter Monitor
• Version Model Number: Model 950-3CH
• Catalog Number: 1
• Company DUNS: 001048925
• Company Name: MEMTEC CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002827308 [Primary]

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-25
• Device Publish Date: 2019-11-15

Devices Manufactured by MEMTEC CORPORATION

• 00860002827308 - Holter Monitor: 2019-11-25Holter Monitor
• 00860002827308 - Holter Monitor: 2019-11-25 Holter Monitor
• 00860002827315 - MobileECG System: 2019-11-25 PC Based Wireless 12 Lead EKG Device