Nimbus

GUDID 00817170020154

This is a plastic box outside a drug bag less than or equal to 100ml.

INFUTRONIX LLC

Patient-controlled analgesia infusion pump

• Primary Device ID: 00817170020154
• NIH Device Record Key: 7479b77b-628b-4904-b6ed-5306400ba2c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus
• Version Model Number: Nimbus Hard Shell 100ml
• Company DUNS: 079821136
• Company Name: INFUTRONIX LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817170020154 [Primary]
GS1	10817170020151 [Package]; Package: Inner Pack [20 Units]; In Commercial Distribution
GS1	20817170020158 [Package]; Package: Case [80 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-15
• Device Publish Date: 2019-01-15

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