BioKnit Back Brace 7" Conductive Garment - Kit KB0918423-PAD230

GUDID 00857771003385

Back Brace 7" Conductive Garment with 4- 2x3 Electrodes

BIOMEDICAL LIFE SYSTEMS, INC.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00857771003385
• NIH Device Record Key: 2e2350ee-a5d7-42d5-bf1f-604358e7d3e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioKnit Back Brace 7" Conductive Garment - Kit
• Version Model Number: KB0918423
• Catalog Number: KB0918423-PAD230
• Company DUNS: 116956807
• Company Name: BIOMEDICAL LIFE SYSTEMS, 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: true
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857771003385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053214

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2022-08-03
• Device Publish Date: 2022-07-26

Devices Manufactured by BIOMEDICAL LIFE SYSTEMS, INC.

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• 20857771003594 - 2" x 2" pigtail electrode: 2024-09-03 1 Carton - 5 Inner Boxes / Carton, 10 Pouches / Inner Box, 10 Packs / Pouch. 4 Each / Pack
• 10857771003597 - 2" x 2" pigtail electrode - Inner Box: 2024-08-27 1 Inner Box - 10 Pouches / Inner Box, 10 Packs / Pouch. 4 Each / Pack
• 00850706007304 - 2" x 2" Rectangle Electrodes: 2024-08-15 BioStim 2" x 2" Rectangle Electrodes - 10 pouches of 4 each
• 00857771003422 - Impulse TENS D5: 2024-08-15
• 00857771003354 - BioKnit Conductive Shoulder Support Garment - Kit: 2022-08-03 Conductive Shoulder Garment with 4- 2x3 Electrodes
• 00857771003385 - BioKnit Back Brace 7" Conductive Garment - Kit: 2022-08-03Back Brace 7" Conductive Garment with 4- 2x3 Electrodes
• 00857771003385 - BioKnit Back Brace 7" Conductive Garment - Kit: 2022-08-03 Back Brace 7" Conductive Garment with 4- 2x3 Electrodes
• 00857771003347 - BioKnit conductive sock - universal fit: 2021-05-13 BioKnit conductive sock - universal fit