Nimbus

GUDID 10817170020106

Ambulaotry infusion pump

INFUTRONIX LLC

Patient-controlled analgesia infusion pump

• Primary Device ID: 10817170020106
• NIH Device Record Key: f4127ab3-2e4c-4bd4-8315-3801e7da257a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus
• Version Model Number: Nimbus II EMS
• Company DUNS: 079821136
• Company Name: INFUTRONIX LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817170020109 [Primary]
GS1	10817170020106 [Package]; Contains: 00817170020109; Package: Case [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153193

FDA Product Code

• MEA: Pump, Infusion, Pca

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: 2018-07-06
• Device Publish Date: 2017-08-31

On-Brand Devices [Nimbus]

• 00817170020154: This is a plastic box outside a drug bag less than or equal to 100ml.
• 10817170020106: Ambulaotry infusion pump
• 40817170020046: Administration set
• 40817170020039: Administration set
• 20817170020028: Administration Set
• 20817170020011: Administration set
• 10817170020007: Ambulatory infusion pump