QuikLinq FOB Adapter

GUDID 10851607003003

Adapter for QuikLinq FOB

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system
Primary Device ID10851607003003
NIH Device Record Key2f36c067-c2a4-4b90-b469-a115b1eab025
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuikLinq FOB Adapter
Version Model NumberRMD-210-020
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com
Phone612-789-0013
Emailsupport@medspira.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607003006 [Primary]
GS110851607003003 [Package]
Contains: 00851607003006
Package: Carton [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 Date2025-03-18
Device Publish Date2025-03-10

Devices Manufactured by MEDSPIRA, LLC

10851607003003 - QuikLinq FOB Adapter 2025-03-18Adapter for QuikLinq FOB
10851607003003 - QuikLinq FOB Adapter 2025-03-18 Adapter for QuikLinq FOB
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.