Holter Prep Kit

GUDID 10812345029939

Holter prep kit with AA battery cleared with Vision 5LR recorder

MORTARA INSTRUMENT, INC.

Electrocardiographic ambulatory recorder

• Primary Device ID: 10812345029939
• NIH Device Record Key: 28a983cd-0fc7-4e14-9db2-ee264ad76fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter Prep Kit
• Version Model Number: 043272
• Company DUNS: 062046149
• Company Name: MORTARA INSTRUMENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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

Customer Support Contacts

• Phone: 888-667-8272
• Email: techsupport@mortara.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812345029939 [Primary]
GS1	20812345029936 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	30812345029933 [Package]; Contains: 20812345029936; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945985

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Holter Prep Kit]

• 10812345029939: Holter prep kit with AA battery cleared with Vision 5LR recorder
• 30812345026024: Holter prep kit with AAA battery cleared with H3+ Holter recorder