Commode

GUDID 00851607003228

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system
Primary Device ID00851607003228
NIH Device Record Key28e9a4f3-4218-4a59-af2b-a28c7c7b64c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCommode
Version Model NumberRMD-002-COM
Company DUNS962187964
Company NameMEDSPIRA, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003228 [Primary]
GS110851607003225 [Package]
Package: Shipper [1 Units]
In Commercial Distribution

FDA Product Code

KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01

Devices Manufactured by MEDSPIRA, LLC

00851607003327 - Single Patient Kit, mcompass, Anorectal Manometry 5-channel2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 5-channel
00851607003334 - Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite
10851607003348 - Single Patient Kit, mcompass, Anorectal Manometry 2-channel2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 2-channel
10851607003379 - Medspira Tablet PC with Power Supply2023-10-16 Medspira Tablet PC with Power Supply
10851607003393 - mcompass Anorectal Manometry System2023-10-16 mcompass Anorectal Manometry System
00851607003402 - Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack
10851607003416 - Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack
10851607003423 - Catheter, mcompass®, Biofeedback, 2-channel, 5-pack2023-10-16 Catheter, mcompass®, Biofeedback, 2-channel, 5-pack
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