ESU Sensor ICM-000-0422

GUDID 00817688021742

I.C. MEDICAL, INC.

Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system

Primary Device ID	00817688021742
NIH Device Record Key	e5733fc6-c678-4582-a38f-9cf7d4e4d655
Commercial Distribution Status	In Commercial Distribution
Brand Name	ESU Sensor
Version Model Number	2250
Catalog Number	ICM-000-0422
Company DUNS	616182895
Company Name	I.C. 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	false
Serial Number	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	00817688021742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K932230

FDA Product Code

FYD	Apparatus, Exhaust, Surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-04-08
Device Publish Date	2016-09-24

On-Brand Devices [ESU Sensor]

00817688021742	2250
00817688021711	ICM-000-0009