Aveta Fluid Management Accessory 205-212

GUDID 00850006759248

Aveta Fluid Management Accessory for use with Aveta System

MEDITRINA, INC.

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• Primary Device ID: 00850006759248
• NIH Device Record Key: 4b20eac4-4d84-4106-98ad-8f7f5a36d59e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Fluid Management Accessory
• Version Model Number: 205-212
• Catalog Number: 205-212
• Company DUNS: 080570262
• Company Name: MEDITRINA, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00850006759231 [Primary]
GS1	00850006759248 [Package]; Contains: 00850006759231; Package: shelf carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190372

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [Aveta Fluid Management Accessory]

• 00850006759002: Aveta Fluid Management Accessory for use with Aveta System
• 00850006759248: Aveta Fluid Management Accessory for use with Aveta System