Parker Labs 18-28

GUDID 00855683006272

Signaspray Electrode Solution, one gallon bottle

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 00855683006272
• NIH Device Record Key: 9c0452b2-25c4-4bdf-a1fc-0a4abd0f31d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parker Labs
• Version Model Number: Signaspray Electrode Solution
• Catalog Number: 18-28
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES 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: 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: 19732769500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006272 [Primary]
GS1	10855683006279 [Package]; Package: BOX [1 Units]; In Commercial Distribution
GS1	20855683006276 [Package]; Contains: 10855683006279; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780973

FDA Product Code

• GYB: Media, Electroconductive

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: 2018-10-22
• Device Publish Date: 2016-12-19

On-Brand Devices [Parker Labs]

• 00855683006272: Signaspray Electrode Solution, one gallon bottle
• 00855683006159: Transeptic Cleansing Solution, 50 ml bottle
• 00855683006142: Transeptic Cleansing Solution, 250mL bottle