inSIGHT H12R-4500

GUDID 00816734021965

inSIGHT Legacy Adaptor

DIVERSATEK HEALTHCARE, INC.

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system 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.

• M78312011061 - Diversatek Healthcare: 2024-02-08 Basic Endoscopy Procedure Kit
• 10816734023355 - BullDog®: 2023-09-04 Air/Water Channel Cleaning Adapter for Fujifilm® GI Endoscope
• 00816734023181 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 15 FR
• 00816734023198 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 18 FR
• 00816734023204 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 21 FR
• 00816734023211 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 24 FR
• 00816734023228 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 27 FR
• 00816734023235 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 30 FR