System, mcompass®, ARM + Biofeedback

GUDID 10851607003485

System, mcompass®, ARM + Biofeedback

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system
Primary Device ID10851607003485
NIH Device Record Key029512d8-edb3-4d61-93c2-e79b651c91ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem, mcompass®, ARM + Biofeedback
Version Model NumberRMD-203
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
GS100851607003488 [Primary]
GS110851607003485 [Package]
Contains: 00851607003488
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

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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