ReadyRip Belt 502-0204-2

GUDID B143502020420

Single use, medium respiratory belt.

Cleveland Medical Devices Inc.

Electroencephalograph

• Primary Device ID: B143502020420
• NIH Device Record Key: 75965adf-3b1a-4093-b1a7-f22f23496c76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReadyRip Belt
• Version Model Number: Medium - Single
• Catalog Number: 502-0204-2
• Company DUNS: 557510625
• Company Name: Cleveland Medical Devices 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B143502020420 [Primary]
HIBCC	B14360201301 [Package]; Package: [10 Units]; In Commercial Distribution
HIBCC	B14360201311 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042039

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2016-09-16

On-Brand Devices [ReadyRip Belt]

• B143502020450: Single use, extra extra large respiratory belt.
• B143502020440: Single use, extra large respiratory belt.
• B143502020430: Single use, large respiratory belt.
• B143502020420: Single use, medium respiratory belt.
• B143502020410: Single use, small respiratory belt.