FDA.reportPublic FDA data

MiVu

Primary DI
00816734022900
Brand
MiVu
Company
DIVERSATEK HEALTHCARE, INC.
Model
MI-SYR-01
Catalog number
MI-SYR-01
Device description
MiVu Mucosal Integrity Inflation Syringe and Extension Tubing
Published
2020-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QISEsophageal, Mucosal, Electrical Characterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QISEsophageal, Mucosal, Electrical CharacterizationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816734022907PackageGS15In Commercial Distribution
00816734022900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081673402290710816734022907
00816734022900008167340229008167340229000816734022900

GMDN Terms#

Term, Definition table
TermDefinition
Manometric gastrointestinal motility analysis systemAn assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816734021286InnerVision®1465-401465-402018-09-18
00816734021293InnerVision®1465-501465-502018-09-18
00816734021217InnerVision®1450-021450-022018-09-18
00816734021224InnerVision®1450-401450-402018-09-18
00816734021231InnerVision®1450-501450-502018-09-18
00816734021248InnerVision®1450-561450-562018-09-18
00816734021255InnerVision®1455-401455-402018-09-18
00816734021262InnerVision®1455-501455-502018-09-18
00816734021279InnerVision®1455-561455-562018-09-18
00816734021309InnerVision®1465-561465-562018-09-18
00816734023518BullDog®1203-401203-402025-12-05
10816734023515BullDog®1203-401203-402025-12-05
M78312011160Diversatek Healthcare1201-1161201-1162025-11-14
00816734021682Diversatek HealthcareA86-1070A86-10702023-06-30
00816734021835Diversatek HealthcareA86-4300-10A86-4300-102023-06-30
00816734021859Diversatek HealthcareA86-5070A86-50702023-06-30
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816734023143MiVuDIVERSATEK HEALTHCARE, INC.QIS2023-05-26
00816734023167MiVuDIVERSATEK HEALTHCARE, INC.QIS2023-05-26
00816734023082PriZmDIVERSATEK HEALTHCARE, INC.QIS2022-10-21
00816734021842MiVuDIVERSATEK HEALTHCARE, INC.QIS2020-11-06
00816734022719MiVuDIVERSATEK HEALTHCARE, INC.QIS2020-11-06
00816734022931MiVuDIVERSATEK HEALTHCARE, INC.QIS2020-11-06
00816734022948MiVuDIVERSATEK HEALTHCARE, INC.QIS2020-11-06
00816734022481MiVuDIVERSATEK HEALTHCARE, INC.QIS2020-11-06