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MiVu

FDA UDI

Class II (US FDA UDI)

by Diversatek Healthcare

Identity

Trade Name
MiVu FDA UDI
Generic Name
Manometric gastrointestinal motility analysis system FDA UDI
Device Name
MiVu Esophageal Endo Cap FDA UDI
Model / Reference
MI-ESO-CAP-3L FDA UDI
Description
MiVu Esophageal Endo Cap FDA UDI

Identifiers

Catalog Number
MI-ESO-CAP-3L FDA UDI
Primary DI / UDI-DI
00816734023143 FDA UDI
FDA Product Code
QIS FDA UDI
GMDN Term
Manometric gastrointestinal motility analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Manometric gastrointestinal motility analysis system

MiVu by Diversatek Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manometric gastrointestinal motility analysis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diversatek Healthcare

Sources (1)

  • FDA UDI 4369b737-7bb6-49d8-b344-1be3b99164af 35 fields · synced Jun 8, 2026