Nimbus HS-002

GUDID 40817170020046

Administration set

INFUTRONIX LLC

Electric infusion pump administration set, single-use

• Primary Device ID: 40817170020046
• NIH Device Record Key: 4ce4b824-a5aa-4196-980b-c5e4d1087963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus
• Version Model Number: HS-002
• Catalog Number: HS-002
• 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: true
• 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	00817170020048 [Primary]
GS1	30817170020049 [Package]; Contains: 00817170020048; Package: Inner pack [20 Units]; In Commercial Distribution
GS1	40817170020046 [Package]; Contains: 30817170020049; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140783

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-31

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