BioStim Plus KBSP

GUDID 00857771003071

BIOMEDICAL LIFE SYSTEMS, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00857771003071
• NIH Device Record Key: 14f72057-5d03-4270-846b-02de8369398f
• Commercial Distribution Discontinuation: 2020-01-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BioStim Plus
• Version Model Number: BioStim Plus
• Catalog Number: KBSP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: 7607275600
• Email: information@bmls.com

Device Dimensions

• Height: 6 Inch
• Height: 6 Inch
• Height: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857771003071 [Primary]
GS1	10857771003078 [Package]; Package: [60 Units]; Discontinued: 2020-01-28; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022841

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-28
• Device Publish Date: 2016-09-23

Devices Manufactured by BIOMEDICAL LIFE SYSTEMS, INC.

• 00857771003590 - 2" x 2" pigtail electrode: 2024-09-03 1 Pouch - 10 Packs / Pouch. 4 Each / PaCK.
• 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: 2022-08-03 Back Brace 7" Conductive Garment with 4- 2x3 Electrodes
• 00857771003347 - BioKnit conductive sock - universal fit: 2021-05-13 BioKnit conductive sock - universal fit