Sandhill Scientific ZAI-BG-44

GUDID B019ZAIBG440

Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm

DIVERSATEK HEALTHCARE, INC.

Oesophageal motility analysis system

• Primary Device ID: B019ZAIBG440
• NIH Device Record Key: bdf3bbf5-5be8-4e32-9a4f-73c896b07de3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sandhill Scientific
• Version Model Number: ZAI-BG-44
• Catalog Number: ZAI-BG-44
• 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: 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: 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

Device Dimensions

• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French
• Catheter Gauge: 6.9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734022207 [Secondary]
HIBCC	B019ZAIBG440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012232

FDA Product Code

• FFT: Electrode, Ph, Stomach
• 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: 5
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-24

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