InfuseOne 42357-01

GUDID 20889483230777

Intravenous pressure infusor, manual, reusable

Primary Device ID	20889483230777
NIH Device Record Key	4e32b4d8-2db2-4425-be21-8f9bb0b9e59a
Commercial Distribution Status	In Commercial Distribution
Brand Name	InfuseOne
Version Model Number	42357-01
Catalog Number	42357-01
Company DUNS	079149179
Company Name	ETHOX MEDICAL, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	true
MRI Safety Status	MR Conditional
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10889483230770 [Primary]
GS1	20889483230777 [Package] Contains: 10889483230770 Package: BX [5 Units] In Commercial Distribution
GS1	30889483230774 [Package] Contains: 10889483230770 Package: Case [25 Units] In Commercial Distribution

KZD	Infusor, Pressure, For I.V. Bags

Steralize Prior To Use	false
Device Is Sterile	false

20889483230784	3000ml ICU Medical InfuseOne Pressure Infusion Bag
20889483230777	3000ml ICU Medical InfuseOne Pressure Infusion Bag

Mark Image Registration \| Serial	Company Trademark Application Date
INFUSEONE 85604194 4491725 Live/Registered	ICU Medical, Inc. 2012-04-20