NRFit

GUDID 30610586044018

ICU MEDICAL, INC.

Infusion pump cassette

• Primary Device ID: 30610586044018
• NIH Device Record Key: 7ec461bf-8578-4588-ba9d-d0b3f74374b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NRFit
• Version Model Number: 21-7609-24
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10610586044014 [Primary]
GS1	30610586044018 [Package]; Contains: 10610586044014; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162219

FDA Product Code

• PWH: Administrations sets with neuraxial connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-04-23
• Device Publish Date: 2017-09-21

On-Brand Devices [NRFit]

• 30610586044742: 21-7624-24
• 30610586044117: 21-7605-24
• 30610586044025: 21-7664-24
• 30610586044018: 21-7609-24
• 30610586044001: 21-7600-24
• 30610586043998: 21-7608-24
• 30610586043974: 21-7639-24
• 30610586043844: 24-1009-64
• 30610586043837: 24-1004-64
• 30610586043820: 24-1001-64