AY-631P-QM

GUDID 04931921101483

Single-patient intensive/general healthcare physiologic monitoring system

Primary Device ID	04931921101483
NIH Device Record Key	3c1cf820-089a-4d6b-a90f-be5da7f20d55
Commercial Distribution Status	In Commercial Distribution
Version Model Number	AY-631P
Catalog Number	AY-631P-QM
Company DUNS	690568050
Company Name	NIHON KOHDEN CORPORATION
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	04931921101483 [Primary]

MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Steralize Prior To Use	false
Device Is Sterile	false

04931921044353 - cap-ONE`	2024-07-01 Airway adapter for adult and child
04931921017524 - NA	2024-02-02 Receiver unit for ZS, ZM series
04931921017159 - CNS-2101 Central Monitor	2023-11-07 Central Monitor
04931921007723 - Nihon Kohden, EEG-1200A Series Neurofax	2023-10-09 Cart, used with EEG-1200A, works with standard and optional accessories
04931921007730 - Nihon Kohden, EEG-1200A Series Neurofax	2023-10-09 Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
04931921017166 - CNS-2101 Central Monitor	2023-10-09 Central Monitor
04931921010235 - cap-ONE	2023-05-30 cap-ONE Nasal Adapter, Adult
04931921010273 - cap-ONE	2023-05-30 cap-ONE Nasal Adapter, Adult, w/ Oxygen tube