inSIGHT Ultima H12R-2000

GUDID 00816734021941

InSight Ultima® Central Unit

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 ID00816734021941
NIH Device Record Keya343d292-3343-4d11-b869-ef377bea980f
Commercial Distribution StatusIn Commercial Distribution
Brand NameinSIGHT Ultima
Version Model NumberH12R-2000
Catalog NumberH12R-2000
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816734021941 [Primary]
HIBCCB019H12R20000 [Secondary]

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2023-06-14
Device Publish Date2016-09-24

On-Brand Devices [inSIGHT Ultima]

00816734023112inSIGHT Ultima Base System
00816734023105inSIGHT Ultima Base Cart System
00816734021958inSight Ultima® EMG Adaptor
00816734021941InSight Ultima® Central Unit

Trademark Results [inSIGHT Ultima]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSIGHT ULTIMA
INSIGHT ULTIMA
86504174 4799320 Live/Registered
Sandhill Scientific, Inc.
2015-01-15
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