NoiseFree™

GUDID 10816843021037

REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), RIBBON, PVC WIRE

ROCHESTER ELECTRO-MEDICAL, INC.

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• Primary Device ID: 10816843021037
• NIH Device Record Key: 9f1523d0-6b83-4c0d-93fc-086a5a05dcc9
• Commercial Distribution Discontinuation: 2019-05-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NoiseFree™
• Version Model Number: S015315
• Company DUNS: 068156330
• Company Name: ROCHESTER ELECTRO-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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com
• Phone: 18003285544
• Email: info@rochestermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816843021037 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2022-11-28
• Device Publish Date: 2016-09-24

On-Brand Devices [NoiseFree™]

• 10816843021136: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 4 FT. (1.2 M), SINGLE, SILICO
• 10816843021112: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 8 FT. (2.5 M), SINGLE, SILICONE WIRE
• 10816843021099: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE
• 10816843021075: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 8 FT. (2.5 M), SINGLE, SILICO
• 10816843021051: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 6 FT. (1.8 M), SINGLE, SILICO
• 10816843021037: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), RIBBON, PVC WIRE