Vital Signs™ IN900012-CE

GUDID 30889483642386

Vital Signs™ Pressure Infusor

SUNMED, LLC

Intravenous pressure infusor, manual, reusable

• Primary Device ID: 30889483642386
• NIH Device Record Key: 2275eb83-a49b-4282-a313-532c6f5607e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs™
• Version Model Number: IN900012-CE
• Catalog Number: IN900012-CE
• Company DUNS: 069009268
• Company Name: SUNMED, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Operating and Storage Conditions

• Storage Environment Humidity: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752133754 [Previous]
GS1	10889483642382 [Primary]
GS1	30889483642386 [Package]; Contains: 10889483642382; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• KZD: Infusor, Pressure, For I.V. Bags

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: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [Vital Signs™]

• 30889483642409: Vital Signs™ Pressure Infusor
• 30889483642386: Vital Signs™ Pressure Infusor
• 30889483642362: Vital Signs™ Pressure Infusor
• 30889483642355: Vital Signs™ Head Positioner