Baxter Baxter-022

GUDID 20185098000843

(1600) Baxter Electrodes 2.0"x2.0" Black Foam (400 packs per case - 4 electrodes per pack = 1600 pieces)

PRO MEDICAL SUPPLIES, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 20185098000843
• NIH Device Record Key: febd96b7-c0e2-4f5a-9426-e40c229b4344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baxter
• Version Model Number: Baxter-022
• Catalog Number: Baxter-022
• Company DUNS: 135741127
• Company Name: PRO MEDICAL SUPPLIES, INC.
• Device Count: 1600
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18509800084916 [Unit of Use]
GS1	20185098000843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132998

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [Baxter]

• 00185098000849: Baxter Electrodes 2.0"x2.0" Black Foam (1 Pack = 4 Electrodes Per Pack)
• 20185098000843: (1600) Baxter Electrodes 2.0"x2.0" Black Foam (400 packs per case - 4 electrodes per pack = 1600
• 10185098000846: (400) Baxter Electrodes 2.0"x2.0" Black Foam (100 Pack = 4 Electrodes Per Pack)