BioKnit Conductive Garment KB0961

GUDID 00857771003552

qty 2 ea/pk with 2 x 3 electrodes

BIOMEDICAL LIFE SYSTEMS, INC.

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: 00857771003552
• NIH Device Record Key: 40c947e1-45ce-46a4-925b-5b2ec47ea324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioKnit Conductive Garment
• Version Model Number: KB0961 univ. cervical
• Catalog Number: KB0961
• 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: 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: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com
• Phone: 7607275600
• Email: information@bmls.com

Device Dimensions

• Width: 1 Inch
• Width: 1 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch
• Height: 8 Inch
• Length: 11 Inch
• Width: 1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857771003552 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-28
• Device Publish Date: 2016-09-23

On-Brand Devices [BioKnit Conductive Garment]

• 00857771003552: qty 2 ea/pk with 2 x 3 electrodes
• 00857771003545: sport shoulder univ with 4- 2x3 electrodes