Zvu ZVU-2016

GUDID 00816734022429

Zvu® Advanced GI Diagnostic Software

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 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 ID00816734022429
NIH Device Record Key56aabffd-c017-4832-a380-9479bca1bdf0
Commercial Distribution StatusIn Commercial Distribution
Brand NameZvu
Version Model NumberZVU-2016
Catalog NumberZVU-2016
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 Batchtrue
Serial Numberfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816734022429 [Primary]
HIBCCB019ZVU20160 [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

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00816734023181 - SafeGuide® Single2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 15 FR
00816734023198 - SafeGuide® Single2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 18 FR
00816734023204 - SafeGuide® Single2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 21 FR
00816734023211 - SafeGuide® Single2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 24 FR
00816734023228 - SafeGuide® Single2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 27 FR
00816734023235 - SafeGuide® Single2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 30 FR
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