Plum 360 30010

GUDID M3353001004091

Plum 360 Infuser

ICU MEDICAL, INC.

Bedside infusion pump, single-channel

• Primary Device ID: M3353001004091
• NIH Device Record Key: b5b90eaa-4dd3-4af1-97dc-b76dd9ac4d26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plum 360
• Version Model Number: 300100409
• 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

• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 8 Inch
• Depth: 6 Inch
• Length: 8 Inch
• Height: 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	M3353001004091 [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