Rochester

GUDID 10816843021297

DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 6 FT (1.8 M) WIRES

ROCHESTER ELECTRO-MEDICAL, INC.

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: 10816843021297
• NIH Device Record Key: 29943dbb-3568-4dbb-a01d-f392a6aedc0e
• Commercial Distribution Discontinuation: 2019-05-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rochester
• Version Model Number: 222466
• Company DUNS: 068156330
• Company Name: ROCHESTER ELECTRO-MEDICAL, INC.
• Device Count: 4
• 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

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
• 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	10816843021273 [Primary]
GS1	10816843021280 [Unit of Use]
GS1	10816843021297 [Package]; Contains: 10816843021273; Package: [50 Units]; Discontinued: 2019-05-20; Not in Commercial Distribution

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: 5
• Public Version Date: 2023-12-18
• Device Publish Date: 2016-09-24

On-Brand Devices [Rochester]

• 10816843021211: REPLACEMENT STAMPED ELECTRODE DISCS: 9 MM STAMPED TIN DISCS
• 10816843021198: REPLACEMENT STAMPED ELECTRODE DISCS: 6 MM STAMPED TIN DISCS
• 10816843021174: REUSABLE EAR CLIP ELECTRODES: 9 MM GOLD DISC, 6 FT. (1.8 M), PVC WIRE
• 10816843021150: REUSABLE EAR CLIP ELECTRODES: 9MM SILVER DISC, 6 FT. (1.8 M), PVC WIRE
• 10816843021297: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 6 FT (1.8 M) WIRES
• 10816843023765: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 6 FT (1.8 M) WIRES
• 10816843023741: DISPOSABLE PRE-GELLED SURFACE ELECTRODES: 3 FT (0.9 M) WIRES
• 10816843020085: REUSABLE DIGITAL RING ELECTRODES: RED & BLACK, 2 FT. (0.61 M), HEAVY-DUTY WIRE
• 10816843020061: REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 4 FT (1.2 M), HEAVY-
• 10816843020047: REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 30" (0.76 M), HEAVY-
• 10816843020023: REUSABLE FIXED BAR ELECTRODES: 9 MM TIN DISC, 3 CM BETWEEN DISCS, 4 FT. (1.2M), TWISTED WIRE
• 10816843020009: REUSABLE TIN SKIN PICK-UP DISC ELECTRODES: 9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED W