Biotronik Neptune

GUDID 00811331011456

Biotronik Neptune Pad

Tz Medical, Inc.

Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing

• Primary Device ID: 00811331011456
• NIH Device Record Key: bc1e11c7-6c60-413e-b932-a0b12d3eb3fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronik Neptune
• Version Model Number: 8870-02
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811331011456 [Unit of Use]
GS1	00811331011463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040208

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-10-24
• Device Publish Date: 2023-10-16

Devices Manufactured by Tz Medical, Inc.

• 00811331011470 - ARC Adjustable Radial Cuff: 2023-11-23 ARC Adjustable Radial Cuff- Large
• 00811331011333 - ARC Adjustable Radial Cuff: 2023-11-23 ARC Adjustable Radial Cuff- Small
• 00811331013917 - H3R USB Cable: 2023-11-23 H3R USB Cable
• 00811331013931 - H3R Holster: 2023-11-23 H3R Holster (Rev A)
• 00811331013245 - TZ Medical Pressure Discs: 2023-10-30 Round Universal Disc
• 00811331011210 - EZ Holder: 2023-10-30 EZ Holder
• 00811331011647 - TruBrite Adhesive Retractor Light: 2023-10-30 Adhesive Retractor Light
• 00811331011715 - TZ Medical Pressure Discs: 2023-10-30 Oval Universal Disc