Zvu® HRAM-100

GUDID 00816734022740

HRAM Protocol for BioView

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
Primary Device ID00816734022740
NIH Device Record Key3567d737-95e4-48f3-8d0c-79b972df77c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameZvu®
Version Model NumberHRAM-100
Catalog NumberHRAM-100
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 Numberfalse
Manufacturing Datetrue
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@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com
Phone800-558-6408
Emailsales@diversatek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816734022740 [Primary]
GS100816734022740 [Primary]
GS100816734022740 [Primary]
GS100816734022740 [Primary]
GS100816734022740 [Primary]
GS100816734022740 [Primary]
GS100816734022740 [Primary]
GS100816734022740 [Primary]

FDA Product Code

FFXSystem, Gastrointestinal Motility (Electrical)
FFXSystem, Gastrointestinal Motility (Electrical)
FFXSystem, Gastrointestinal Motility (Electrical)
FFXSystem, Gastrointestinal Motility (Electrical)
FFXSystem, Gastrointestinal Motility (Electrical)
FFXSystem, Gastrointestinal Motility (Electrical)
FFXSystem, Gastrointestinal Motility (Electrical)
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 Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Zvu®]

00816734022924Zvu® HRAM Starter Kit
00816734022917Zvu® HRiM Probe Kit
00816734022863Zvu® Anorectal Manometry Procedure Kit
00816734022856Zvu® Anorectal Balloons
00816734022740HRAM Protocol for BioView
00816734022733Zvu® HRAM Probe
00816734022689Zvu® HRiM Probe

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