inSIGHT H12R-4500

GUDID 00816734021965

inSIGHT Legacy Adaptor

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system

• Primary Device ID: 00816734021965
• NIH Device Record Key: 686d32c3-5a74-4ec7-a46f-0ca3716045f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inSIGHT
• Version Model Number: H12R-4500
• Catalog Number: H12R-4500
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734021965 [Primary]
HIBCC	B019H12R45000 [Secondary]

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2023-06-14
• Device Publish Date: 2016-09-24

Devices Manufactured by DIVERSATEK HEALTHCARE, INC.

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• 00816734023464 - Diversatek Healthcare: 2025-05-26 High Resolution Anorectal Manometry Probe Kit
• 00816734023471 - Diversatek Healthcare: 2025-05-26 Anal Sphincter Electromyography Kit
• 00816734023488 - Diversatek Healthcare: 2025-05-26 Desktop PC with Zvu Software
• 00816734023426 - Zvu®: 2025-04-03 Zvu® Functional GI Software Revision 3.4.0
• 10816734023416 - BullDog®: 2024-12-02 Disposable Endoscope Valves Set