Plum 360 30010

GUDID M3353001004101

Plum 360 Infuser

ICU MEDICAL, INC.

Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

Primary Device ID	M3353001004101
NIH Device Record Key	b904c545-785b-43eb-ba58-939c1f592257
Commercial Distribution Status	In Commercial Distribution
Brand Name	Plum 360
Version Model Number	300100410
Catalog Number	30010
Company DUNS	118380146
Company Name	ICU 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

Customer Support Contacts

Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com
Phone	+1(800)241-4002
Email	TSC.Support@icumed.com

Device Dimensions

Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch
Height	8 Inch
Length	8 Inch
Depth	6 Inch

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius
Special Storage Condition, Specify	Between 0 and 0 *Low Value is negative 20 degree Celsius. High Value is 60 degree Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M3353001004101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161469

FDA Product Code

FRN	Pump, infusion

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	2022-07-04
Device Publish Date	2018-12-11

On-Brand Devices [Plum 360]

M3353001004141	Plum 360 Infuser
M3353001004131	Plum 360 Infuser
M3353001004101	Plum 360 Infuser
M3353001004091	Plum 360 Infuser
M3353001004081	Plum 360 Infuser
M3353001004071	Plum 360 Infuser
M3353001004061	Plum 360 Infuser

Trademark Results [Plum 360]

Mark Image Registration \| Serial	Company Trademark Application Date
PLUM 360 85956799 4846470 Live/Registered	Hospira, Inc. 2013-06-11