BF-3

GUDID 30816625020023

1.875" X 3.75" Rectangular electrode patch in pouch of 4 each electrodes.

Bio Medical Innovations

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 30816625020023
• NIH Device Record Key: 322bf204-6f62-4b68-86c6-5aa9bf165df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BF-3
• Version Model Number: TENS
• Company DUNS: 173358318
• Company Name: Bio Medical Innovations
• 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: 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

Customer Support Contacts

• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com
• Phone: 2082635071
• Email: dmcelroy@biomedical-innovations.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816625020022 [Primary]
GS1	10816625020029 [Package]; Contains: 00816625020022; Package: Inner Pack [20 Units]; In Commercial Distribution
GS1	30816625020023 [Package]; Contains: 10816625020029; Package: Case [4 Units]; 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-03

Devices Manufactured by Bio Medical Innovations

• 30816625020108 - SS-5: 2020-02-17 2.0" Round electrode patch in pouch of 4 each electrodes
• 30816625020016 - BF-2: 2018-03-29 2" X 2" Square electrode patch in pouch of 4 each electrodes.
• 30816625020023 - BF-3: 2018-03-291.875" X 3.75" Rectangular electrode patch in pouch of 4 each electrodes.
• 30816625020023 - BF-3: 2018-03-29 1.875" X 3.75" Rectangular electrode patch in pouch of 4 each electrodes.
• 30816625020030 - BF-4: 2018-03-29 1.25" Round electrode patch in pouch of 4 each electrodes.
• 30816625020047 - BF-5: 2018-03-29 2.0" Round electrode patch in pouch of 4 each electrodes.
• 30816625020054 - BF-6: 2018-03-29 3.0" Round electrode patch in pouch of 4 each electrodes.
• 30816625020061 - BF-7: 2018-03-29 1.25" X 2.25" Oval electrode patch in pouch of 4 each electrodes.
• 30816625020078 - BF-8: 2018-03-29 2.0" X4.0" Oval electrode patch in pouch of 4 each electrodes.