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System, mcompass®, Anorectal Manometry

FDA UDI

Class II (US FDA UDI)

by Medspira Llc

Identity

Trade Name
System, mcompass®, Anorectal Manometry FDA UDI
Generic Name
Manometric gastrointestinal motility analysis system FDA UDI
Device Name
System, mcompass®, Anorectal Manometry (~1/2 Price Replacement) FDA UDI
Model / Reference
RMD-201U FDA UDI
Description
System, mcompass®, Anorectal Manometry (~1/2 Price Replacement) FDA UDI

Identifiers

Primary DI / UDI-DI
00851607003464 FDA UDI
FDA Product Code
KLA FDA UDI
GMDN Term
Manometric gastrointestinal motility analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 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

No

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

Category: Manometric gastrointestinal motility analysis systemRectosphincteric balloon

System, mcompass®, Anorectal Manometry by Medspira Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectosphincteric balloon.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medspira Llc

Sources (1)

  • FDA UDI 67be0aee-06ab-4b93-8379-e61548273599 35 fields · synced May 30, 2026