Cadwell Disposable Patient Pak Refill

GUDID 10840067101343

CADWELL INDUSTRIES, INC.

Electrode conductive medium

• Primary Device ID: 10840067101343
• NIH Device Record Key: 6ca7dc9f-fce5-403d-9059-06b5b6c22a64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell Disposable Patient Pak Refill
• Version Model Number: 302120-000
• Company DUNS: 098554157
• Company Name: CADWELL INDUSTRIES, INC.
• Device Count: 25
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(509)735-6481
• Email: applications@cadwell.com

Device Dimensions

• Length: 1.6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067101346 [Primary]
GS1	10840067101343 [Package]; Contains: 00840067101346; Package: Case [30 Units]; In Commercial Distribution
GS1	20840067101340 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933803

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: 2018-10-22
• Device Publish Date: 2016-09-05

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