Nuwave CO-001

GUDID 00812970012095

NUWAVE Ozone Filter

EXCELERON MEDICAL, INC.

Home CPAP/BPAP washer/disinfector

• Primary Device ID: 00812970012095
• NIH Device Record Key: 38e4a202-9b3b-40df-b4c1-9880fc16241c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuwave
• Version Model Number: CO-001
• Catalog Number: CO-001
• Company DUNS: 825179992
• Company Name: EXCELERON MEDICAL, 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: false
• Lot Batch: true
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812970012095 [Primary]

FDA Product Code

• LRJ: Disinfectant, Medical Devices

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: 2020-10-01
• Device Publish Date: 2020-09-23

On-Brand Devices [Nuwave]

• 00812970012101: NUWAVE Ozone Filter Kit
• 00812970012095: NUWAVE Ozone Filter
• 00812970012088: NUWAVE Large Bag
• 00812970012071: NUWAVE Small Bag
• 00812970012064: NUWAVE Power Supply and Cord
• 00812970012057: NUWAVE Power Cord
• 00812970012040: NUWAVE Power Supply
• 00812970012033: NUWAVE with Small and Large Bag
• 00812970012026: NUWAVE with Large Bag
• 00812970012019: NUWAVE with Small Bag
• 00812970012002: NUWAVE Generator