LED Monitor

GUDID 00851607003235

Manometric gastrointestinal motility analysis system

Primary Device ID	00851607003235
NIH Device Record Key	44d3a921-7bf3-4364-a0f6-1ea0b1b1a470
Commercial Distribution Status	In Commercial Distribution
Brand Name	LED Monitor
Version Model Number	RMD-002-MON
Company DUNS	962187964
Company Name	MEDSPIRA, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00851607003235 [Primary]
GS1	10851607003232 [Package] Package: shipper [1 Units] Discontinued: 2023-12-29 Not in Commercial Distribution

KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube

Steralize Prior To Use	false
Device Is Sterile	false

00851607003327 - Single Patient Kit, mcompass, Anorectal Manometry 5-channel	2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 5-channel
00851607003334 - Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite	2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite
10851607003348 - Single Patient Kit, mcompass, Anorectal Manometry 2-channel	2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 2-channel
10851607003379 - Medspira Tablet PC with Power Supply	2023-10-16 Medspira Tablet PC with Power Supply
10851607003393 - mcompass Anorectal Manometry System	2023-10-16 mcompass Anorectal Manometry System
00851607003402 - Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack	2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack
10851607003416 - Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack	2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack
10851607003423 - Catheter, mcompass®, Biofeedback, 2-channel, 5-pack	2023-10-16 Catheter, mcompass®, Biofeedback, 2-channel, 5-pack