Bella Russo

GUDID 00859811008510

Therapy Machine (Non-App)

NUVOMED, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00859811008510
• NIH Device Record Key: 923ae709-ecfd-4153-849c-5903d2be38d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bella Russo
• Version Model Number: INV00564
• Company DUNS: 080809709
• Company Name: NUVOMED, 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: false
• Lot Batch: true
• Serial Number: true
• 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	00859811008510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170205

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2019-10-23
• Device Publish Date: 2019-06-05

Devices Manufactured by NUVOMED, INC.

• 00810110303676 - NuvoMed: 2024-12-23 TFT Pulse Oximeter
• 00859811008947 - NuvoMed: 2024-12-23 Digital Contactless Thermometer
• 00810110303492 - NuvoMed: 2024-10-28 Wrist Blood Pressure Monitor
• 00810110303508 - NuvoMed: 2024-10-28 Arm Blood Pressure Monitor
• 00810110302099 - NuvoMed: 2024-04-01 Compression Hot & Cold Therapy Sleeve - Small
• 00810110302105 - NuvoMed: 2024-04-01 Compression Hot & Cold Therapy Sleeve - Large
• 00810110302112 - NuvoMed: 2024-04-01 Compression Hot & Cold Therapy Sleeve - XL
• 00810110302129 - NuvoMed: 2024-04-01 Compression Hot & Cold Therapy Pad