DianaTM Compounding Workflow System DS2000-04-01

GUDID 00887709125117

Diana Syringe Pump

ICU MEDICAL, INC.

Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system

• Primary Device ID: 00887709125117
• NIH Device Record Key: 1d0609fd-222c-4a1a-9aa1-2584a5154415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DianaTM Compounding Workflow System
• Version Model Number: DS2000-04-01
• Catalog Number: DS2000-04-01
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709125117 [Primary]

FDA Product Code

• NEP: System/device, pharmacy compounding

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-18
• Device Publish Date: 2023-04-10

On-Brand Devices [DianaTM Compounding Workflow System]

• 00887709126770: Diana Web Server Software
• 00887709126749: Diana Workflow Management Software
• 00887709126596: Diana Workflow Management System
• 00887709126589: US Power Cord Assembly, Diana
• 00887709126497: Diana Compounding Workflow System
• 00887709125735: Diana Web Server Tablet
• 00887709125131: Diana Pharmacist Tablet
• 00887709125124: Diana Operator Tablet
• 00887709125117: Diana Syringe Pump