Holter Prep Kit

GUDID 00857175006111

Holter prep kit Each prep kit contains: 1 razor 1 alcohol pad 1 AA battery 1 skin scrubby 1 page of 5 wet gel electrodes 1 patient diary

VECTRACOR INC

Electrocardiographic long-term ambulatory recording support kit

• Primary Device ID: 00857175006111
• NIH Device Record Key: eba78a4b-0095-4cb6-8fac-7325fc6f5c94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter Prep Kit
• Version Model Number: 701900-00
• Company DUNS: 828416359
• Company Name: VECTRACOR INC
• Device Count: 25
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00857175006111 [Primary]
GS1	10857175006118 [Unit of Use]

FDA Product Code

• OJW: Shave Prep Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

Devices Manufactured by VECTRACOR INC

• 00857175006067 - 3L Calibration Syringe: 2023-06-15 The 3L calibration syringe is a hollow cylindrical tube with a nozzle at one end that connects to a VectraCor pneumotachometer,
• 00857175006173 - Universal SmartECG: 2023-06-15 The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via
• 10857175006071 - Plastic Mouthpieces (100): 2020-03-23 Plastic Mouthpieces box of 100
• 40857175006096 - Adhesive Solid Gel Electrodes (pack of 100): 2018-07-06 Resting EKG Tab Electrodes inner pack of 100
• 00857175006012 - Vectraplex CMS: 2018-07-06 Vectraplex Central Monitoring System
• 00857175006029 - VectraplexECG System: 2018-07-06 VectraplexECG System with Cardio Electrical Bio-marker (CEB)
• 00857175006043 - Universal ECG: 2018-07-06 ECG Amplifier
• 00857175006050 - Orbit Spirometer: 2018-07-06 Orbit Spirometer