Sandhill Scientific ULT1-HA-D

GUDID B019ULT1HAD0

InSIGHT Ultima® HRaM System

DIVERSATEK HEALTHCARE, INC.

Oesophageal motility analysis system

• Primary Device ID: B019ULT1HAD0
• NIH Device Record Key: 868a3c14-bdec-44cf-9ee8-462442412474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sandhill Scientific
• Version Model Number: ULT1-HA-D
• Catalog Number: ULT1-HA-D
• 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
• 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
• 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
HIBCC	B019ULT1HAD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012232

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: 5
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-24

On-Brand Devices [Sandhill Scientific]

• B019ZVU20160: ZVU® Advanced GI Diagnostic Software
• B019ZPNBS500: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• B019ZPNBS46E0: Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
• B019ZPNBS460: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• B019ZPNBG07E0: Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
• B019ZPNBG070: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
• B019ZPIBS460: Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
• B019ZPIBG520: Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
• B019ZINBS510: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• B019ZINBS45E0: Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
• B019ZANBT600: Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor
• B019ZANBS01E0: Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
• B019ZANBS010: Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
• B019ZANBG44E0: Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
• B019ZANBG440: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal)
• B019ZANBD310: Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal)
• B019ZAIBS01E0: Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Por
• B019ZAIBS010: Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
• B019ZAIBL560: LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
• B019ZAIBL550: LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
• B019ZAIBL540: LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
• B019ZAIBG44E0: Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
• B019ZAIBG440: Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
• B019ZAIBD310: Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locat
• B019Z072000BB0: ZepHr® Z/pH Recorder
• B019Z072000BA0: ZepHr® pH Recorder
• B019ULT1SIA0: InSIGHT Ultima® System No Workstation No Monitor Int.
• B019ULT1SI0: InSIGHT Ultima® System No Workstation
• B019ULT1S0: InSIGHT Ultima® Base System
• B019ULT1HSDI0: InSIGHT Ultima® HRiM SD System Int.
• B019ULT1HSDD0: InSIGHT Ultima® HRiM SD System
• B019ULT1HPI0: InSIGHT Ultima® HRZ HRM System Int.
• B019ULT1HPD0: InSIGHT Ultima® HRM System
• B019ULT1HI0: InSIGHT Ultima® HRiM2 System Int.
• B019ULT1HD0: InSIGHT Ultima® HRiM2 System
• B019ULT1HCAD0: InSIGHT Ultima® HRCA System, Int.
• B019ULT1HAI0: InSIGHT Ultima® HRaM System, Int.
• B019ULT1HAD0: InSIGHT Ultima® HRaM System
• B019ULT1CIED0: InSIGHT Ultima® Air-Charged Manometry System
• B019S9819257P10: Bioview® Manometry Acquisition Software
• B019S9819256P10: Bioview® Manometry Acquisition Software
• B019S9819255P10: Bioview® Manometry Acquisition Software
• B019PHNSP0: Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
• B019PHNS0: Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
• B019PHN50: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port
• B019PHN210: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing
• B019PHN150: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing
• B019PHN10P0: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
• B019PHN100: Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
• B019PHIS0: Single-Use pH Probe, Infused, Single pH (Esophageal) with LES Port