BodyGuardian

GUDID 00852132007057

Remote Monitoring System Kit

PREVENTICE TECHNOLOGIES, INC.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00852132007057
• NIH Device Record Key: 03de1fa8-8fb7-4416-b5da-03c2665fae63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyGuardian
• Version Model Number: BG1001MAS
• Company DUNS: 859807815
• Company Name: PREVENTICE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852132007057 [Primary]

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

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: 2016-09-21

On-Brand Devices [BodyGuardian]

• 00852132007101: Mini Easy Slide Strip - Acrylic 2003
• 00852132007095: Remote Monitoring System Kit
• 00852132007088: Strip - Silicone 1009 PMI
• 00852132007071: Strip - Acrylic 1008 PMI
• 00852132007064: Base with metal studs
• 00852132007057: Remote Monitoring System Kit
• 00852132007040: Base
• 00852132007033: Strip - Acrylic 1003
• 00852132007026: Strip - Silicone 1007
• 00852132007019: Remote Monitoring System Kit - Intl
• 00852132007002: Remote Monitoring System Kit
• 00852132007163: BodyGuardian Mini Bridge
• 00852132007156: BodyGuardian Mini Plus Remote Monitoring System Kit
• 00852132007149: BodyGuardian Mini Plus Remote Monitoring System Kit
• 00852132007132: BodyGuardian Mini Holter Monitoring System kit
• 00852132007125: BodyGuardian Mini Holter Monitoring System Kit
• 00852132007118: BodyGuardian Mini Biobank kit
• 00852132007200: BodyGuardian Mini Procedure Pack
• 00852132007187: Mini Short Slide Strip - Acrylic
• 00852132007255: Mini Short Slide Strip - Hydrocolloid