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mcompass Anorectal Manometry FOB

FDA UDI

Class II (US FDA UDI)

by Medspira Llc

Identity

Trade Name
mcompass Anorectal Manometry FOB FDA UDI
Generic Name
Manometric gastrointestinal motility analysis system FDA UDI
Device Name
Medspira mcompass Anorectal Manometry FOB FDA UDI
Model / Reference
RMD-001-001 FDA UDI
Description
Medspira mcompass Anorectal Manometry FOB FDA UDI

Identifiers

Catalog Number
RMD-001-001 FDA UDI
Primary DI / UDI-DI
00851607003044 FDA UDI
510(k) Number
K120088 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Manometric gastrointestinal motility analysis system

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

Similar devices

Also classified as Manometric gastrointestinal motility analysis system.

Cleared under the same submission

K120088 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medspira Llc

Sources (1)

  • FDA UDI 179c27de-a1a5-40c1-b609-b70a2ed398b7 35 fields · synced May 30, 2026