BodyGuardian SP1009

GUDID 00852132007088

Strip - Silicone 1009 PMI

PREVENTICE TECHNOLOGIES, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 00852132007088
• NIH Device Record Key: 93127a4e-ef48-4a98-ab15-c943e4cfa67f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyGuardian
• Version Model Number: SP1009
• Catalog Number: SP1009
• Company DUNS: 859807815
• Company Name: PREVENTICE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852132007088 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2018-09-03
• Device Publish Date: 2018-08-01

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