System, mcompass®, Anorectal Manometry

GUDID 10851607003461

System, mcompass®, Anorectal Manometry (~1/2 Price Replacement)

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system
Primary Device ID10851607003461
NIH Device Record Key67be0aee-06ab-4b93-8379-e61548273599
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem, mcompass®, Anorectal Manometry
Version Model NumberRMD-201U
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@medspira.com
Phone612-789-0013
Emailinfo@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
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
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
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
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
GS100851607003464 [Primary]
GS110851607003461 [Package]
Contains: 00851607003464
Package: Box [5 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 Date2023-10-16
Device Publish Date2023-10-06

On-Brand Devices [System, mcompass®, Anorectal Manometry ]

10851607003461System, mcompass®, Anorectal Manometry (~1/2 Price Replacement)
10851607003454System, mcompass®, Anorectal Manometry

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