CardioHolter

GUDID 00851074007040

Holter Recorder

DATRIX LLC

Electrocardiographic ambulatory recorder

• Primary Device ID: 00851074007040
• NIH Device Record Key: 2de199ba-d71a-4296-bc84-36c47f8fcaa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioHolter
• Version Model Number: VX3+ Series A
• Company DUNS: 080555401
• Company Name: DATRIX LLC
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 651-636-9770
• Email: udi@intricon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851074007040 [Primary]

FDA Product Code

• MWJ: Electrocardiograph,Ambulatory(Without Analysis)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-09

Devices Manufactured by DATRIX LLC

• 00851074007385 - CardioLabs: 2019-11-08 ECG Recorder (Event)
• 00851074007392 - TLC Diagnostics: 2019-11-08 ECG recorder
• 00851074007361 - Datrix: 2019-11-08 ECG Recorder
• 00851074007002 - Sirona: 2019-11-08 ECG Recorder
• 00851074007019 - VX3+: 2019-11-08 Holter Recorder
• 00851074007026 - VX3+: 2019-11-08 Holter Recorder
• 00851074007033 - BodyGuardian: 2019-11-08 Holter Recorder
• 00851074007040 - CardioHolter: 2019-11-08Holter Recorder
• 00851074007040 - CardioHolter: 2019-11-08 Holter Recorder