MRQD42415

GUDID 00816312026849

4 Array MR/CT Conditional Quick Connect, 180mm Deep Cup, 1.5m in (1) Bundle and (1) MR Sticky Pad, 1.5m – 24 Pack

RHYTHMLINK INTERNATIONAL, LLC

Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use

• Primary Device ID: 00816312026849
• NIH Device Record Key: 5069906a-a0b1-4e7a-a5c7-fad8fbf9f346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRQD42415
• Version Model Number: MRQD42415
• Company DUNS: 126290993
• Company Name: RHYTHMLINK INTERNATIONAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816312026849 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

Devices Manufactured by RHYTHMLINK INTERNATIONAL, LLC

• 10816312027300 - Rhythmlink®: 2024-07-15 (3) Array MR/CT Quick Connect, 180mm Deep Cups, 1.5m (23 Pack)
• 10816312027294 - Rhythmlink®: 2024-06-26 (3) Array MR/CT Conditional Quick Connect, 180mm Deep Cups 1.5m (23 Pack)
• 10816312027287 - Rhythmlink®: 2024-06-24 (2) Array MR/CT Quick Connect, 180mm Deep Cups, 1.5m (20 Pack)
• 10816312027249 - Rhythmlink®: 2024-06-10 (3) Arrays MR/CT Quick Connect, 180mm Deep Cups, Slim Cups, Webbs, 1.5m (21 Pack)
• 10816312027256 - Rhythmlink®: 2024-06-10 40 Pouches of MR Recording Small 15x20mm Sticky Pad, 2.5m
• 10816312027263 - Rhythmlink®: 2024-06-10 (3) Arrays MR/CT Quick Connect, 180mm Deep Cups, Slim Cups, Webbs, 1.5m (17 Pack)
• 00816312027273 - Rhythmlink®: 2024-06-06 30 InvisaDeep Cup™ EEG Electrodes
• 00816312027235 - Rhythmlink®: 2024-06-03 Disposable Deep EEG Cup Electrodes and Webb EEG Electrodes