H200 Wireless System

GUDID 00810188050441

Transcutaneous electrical stimulation electrode, reusable

Primary Device ID	00810188050441
NIH Device Record Key	bccfd84a-2dce-4432-b93c-f7df779637e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	H200 Wireless System
Version Model Number	H2W-5D00
Company DUNS	119378513
Company Name	Bioness Medical, Inc.
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	true
Serial Number	false
Manufacturing Date	true
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	00810188050441 [Primary]
GS1	00815962020511 [Previous]

GZI	Stimulator, Neuromuscular, External Functional

Steralize Prior To Use	false
Device Is Sterile	false

00810188050434	H200 Wireless Clinician Upgrade Kit
00810188050427	H200 Wireless Clinician Kit, Large
00810188050410	H200 Wireless Clinician Kit, Small / Medium
00810188050403	H200 Wireless System Kit, Right (Large)
00810188050397	H200 Wireless System Kit, Left (Large)
00810188050380	H200 Wireless System Kit, Right (Medium)
00810188050373	H200 Wireless System Kit, Left (Medium)
00810188050366	H200 Wireless System Kit, Right (Small)
00810188050359	H200 Wireless System Kit, Left (Small)
00810188050441	Cloth Electrodes Set