HAMILTON-C1 161001

GUDID 07630002800747

Hamilton Medical AG

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

Primary Device ID	07630002800747
NIH Device Record Key	43507655-76e8-4ab1-a3e4-9a41b716f5ee
Commercial Distribution Status	In Commercial Distribution
Brand Name	HAMILTON-C1
Version Model Number	161001
Catalog Number	161001
Company DUNS	481492312
Company Name	Hamilton Medical AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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	07630002800747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140939

FDA Product Code

CBK	Ventilator, Continuous, Facility Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-21

On-Brand Devices [HAMILTON-C1]

07630002800747	161001
07630002813426	1610010