mcompass Petite Anorectal Manometry 5-Channel Catheter

GUDID 00851607003198

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system
Primary Device ID00851607003198
NIH Device Record Keyf0c63bdf-f7dd-4a41-8912-8d270daa2df8
Commercial Distribution StatusIn Commercial Distribution
Brand Namemcompass Petite Anorectal Manometry 5-Channel Catheter
Version Model NumberRMD-002-007
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Product should be kept dry.
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Product should be kept dry.
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Product should be kept dry.
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Product should be kept dry.
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003198 [Primary]
GS100851607003198 [Primary]
GS100851607003198 [Primary]
GS100851607003198 [Primary]
GS110851607003195 [Package]
Package: [5 Units]
In Commercial Distribution
GS110851607003195 [Package]
Package: [5 Units]
In Commercial Distribution
GS110851607003195 [Package]
Package: [5 Units]
In Commercial Distribution
GS110851607003195 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
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 Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by MEDSPIRA, LLC

00851607003198 - mcompass Petite Anorectal Manometry 5-Channel Catheter2020-11-10
00851607003198 - mcompass Petite Anorectal Manometry 5-Channel Catheter2020-11-10
20851607003017 - 1.5T BC-10 Transmit/Receive MRI Coil2020-03-05 Medspira 1.5T BC-10 Transmit/Receive MRI Coil
20851607003024 - 3.0T BC-10 Transmit/Receive MRI Coil2020-03-05 Medspira 3.0T BC-10 Transmit/Receive MRI Coil
20851607003185 - mcompass Extension Tube Set2019-11-08 Medspira mcompass Extension Tube Set
20851607003031 - mcompass Anorectal Manometry Catheter2019-11-08 Medspira mcompass 5 Channel Anorectal Manometry Catheter
00851607003044 - mcompass Anorectal Manometry FOB2019-11-08 Medspira mcompass Anorectal Manometry FOB
10851607003058 - mcompass Anorectal Manometry System2019-11-08 Medspira mcompass Diagnostic Anorectal Manometry system
10851607003065 - mcompass Biofeedback Manometry System2019-11-08 Medspira Biofeedback Anorectal Manometry System

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