mcompass Extension Tube Set RMD-002-006

GUDID 20851607003185

Medspira mcompass Extension Tube Set

MEDSPIRA, LLC

Rectosphincteric balloon
Primary Device ID20851607003185
NIH Device Record Key196d1cc3-c80d-4a74-93be-78677455db14
Commercial Distribution StatusIn Commercial Distribution
Brand Namemcompass Extension Tube Set
Version Model NumberRMD-002-006
Catalog NumberRMD-002-006
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
Emailinfo@medspira.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003181 [Primary]
GS110851607003188 [Package]
Contains: 00851607003181
Package: Box [5 Units]
In Commercial Distribution
GS120851607003185 [Package]
Contains: 10851607003188
Package: Shipper [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLAMonitor, Esophageal Motility, And Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2019-06-25

Devices Manufactured by MEDSPIRA, LLC

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10851607003539 - 5-Pack, Luer-Locking, 100cc Syringe2025-03-11 100cc Syringe, Luer-Locking, 5-Pack
10851607003515 - 5-Pack, 100 cc Syringe, Luer-locking2024-12-30 Syringe, Luer-Locking, 100cc, 5-Pack
10851607003386 - System Accessory Kit2024-12-09 Accessories for mcompass systems
00851607003525 - Battery, Tablet PC2024-12-09 Battery for Tablet PC
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
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