Sandhill Scientific ULTSYS

GUDID 00816734022153

InSIGHT Ultima® Manometry System

DIVERSATEK HEALTHCARE, INC.

Oesophageal motility analysis system Oesophageal motility analysis system Oesophageal 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 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 Manometric gastrointestinal motility analysis system
Primary Device ID00816734022153
NIH Device Record Key47099dcf-eb13-4092-be5e-fa9d8aa86143
Commercial Distribution StatusIn Commercial Distribution
Brand NameSandhill Scientific
Version Model NumberULTSYS
Catalog NumberULTSYS
Company DUNS030650113
Company NameDIVERSATEK HEALTHCARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com
Phone800-558-6408
Emailsales@diversatekhc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816734022153 [Secondary]
HIBCCB019ULTSYS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-17
Device Publish Date2019-04-09

On-Brand Devices [Sandhill Scientific]

B019ZVU20160ZVU® Advanced GI Diagnostic Software
B019ZPNBS500Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
B019ZPNBS46E0Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
B019ZPNBS460Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
B019ZPNBG07E0Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
B019ZPNBG070Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
B019ZPIBS460Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
B019ZPIBG520Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
B019ZINBS510Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
B019ZINBS45E0Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
B019ZANBT600Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor
B019ZANBS01E0Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
B019ZANBS010Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
B019ZANBG44E0Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
B019ZANBG440Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal)
B019ZANBD310Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal)
B019ZAIBS01E0Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Por
B019ZAIBS010Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
B019ZAIBL560LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
B019ZAIBL550LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
B019ZAIBL540LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
B019ZAIBG44E0Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
B019ZAIBG440Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
B019ZAIBD310Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locat
B019Z072000BB0ZepHr® Z/pH Recorder
B019Z072000BA0ZepHr® pH Recorder
B019ULT1SIA0InSIGHT Ultima® System No Workstation No Monitor Int.
B019ULT1SI0InSIGHT Ultima® System No Workstation
B019ULT1S0InSIGHT Ultima® Base System
B019ULT1HSDI0InSIGHT Ultima® HRiM SD System Int.
B019ULT1HSDD0InSIGHT Ultima® HRiM SD System
B019ULT1HPI0InSIGHT Ultima® HRZ HRM System Int.
B019ULT1HPD0InSIGHT Ultima® HRM System
B019ULT1HI0InSIGHT Ultima® HRiM2 System Int.
B019ULT1HD0InSIGHT Ultima® HRiM2 System
B019ULT1HCAD0InSIGHT Ultima® HRCA System, Int.
B019ULT1HAI0InSIGHT Ultima® HRaM System, Int.
B019ULT1HAD0InSIGHT Ultima® HRaM System
B019ULT1CIED0InSIGHT Ultima® Air-Charged Manometry System
B019S9819257P10Bioview® Manometry Acquisition Software
B019S9819256P10Bioview® Manometry Acquisition Software
B019S9819255P10Bioview® Manometry Acquisition Software
B019PHNSP0Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
B019PHNS0Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
B019PHN50Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port
B019PHN210Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing
B019PHN150Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing
B019PHN10P0Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
B019PHN100Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
B019PHIS0Single-Use pH Probe, Infused, Single pH (Esophageal) with LES Port

Trademark Results [Sandhill Scientific]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SANDHILL SCIENTIFIC
SANDHILL SCIENTIFIC
76278118 2575982 Live/Registered
Sandhill Scientific, Inc.
2001-06-28

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