Compact Plus

GUDID 00815871020237

Avante

Foetal cardiac monitor Foetal cardiac monitor Foetal cardiac monitor

• Primary Device ID: 00815871020237
• NIH Device Record Key: 6b956e1c-3cfe-418e-a501-5e30971680e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compact Plus
• Version Model Number: 60131
• Company DUNS: 178440426
• Company Name: Avante
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815871020237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150901

FDA Product Code

• HGM: System, Monitoring, Perinatal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-02
• Device Publish Date: 2016-09-23

On-Brand Devices [Compact Plus]

• 00815871020282: 60131EXPI
• 00815871020275: 60131I
• 00815871020268: 60131EXP2
• 00815871020251: 60131B
• 00815871020244: 60131EXP
• 00815871020237: 60131