System Accessory Kit

GUDID 10851607003386

Manometric gastrointestinal motility analysis system

Primary Device ID	10851607003386
NIH Device Record Key	35d1ac5a-a034-4989-ba63-9bcab3bc61e8
Commercial Distribution Status	In Commercial Distribution
Brand Name	System Accessory Kit
Version Model Number	RMD-010-011
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
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	00851607003389 [Primary]
GS1	10851607003386 [Package] Contains: 00851607003389 Package: Bag [1 Units] In Commercial Distribution

KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube

Steralize Prior To Use	false
Device Is Sterile	false

10851607003515 - 5-Pack, 100 cc Syringe, Luer-locking	2024-12-30 Syringe, Luer-Locking, 100cc, 5-Pack
10851607003386 - System Accessory Kit	2024-12-09Accessories for mcompass systems
10851607003386 - System Accessory Kit	2024-12-09 Accessories for mcompass systems
00851607003525 - Battery, Tablet PC	2024-12-09 Battery for Tablet PC
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