Nimbus II PainPRO

GUDID 10817170020083

Ambulatory infusion pump

INFUTRONIX LLC

Patient-controlled analgesia infusion pump

• Primary Device ID: 10817170020083
• NIH Device Record Key: ed7228c2-30ff-43b7-8e32-c000d99cfa81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus II PainPRO
• Version Model Number: Nimbus II PainPRO
• 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	00817170020086 [Primary]
GS1	10817170020083 [Package]; Contains: 00817170020086; Package: Inner Pack [24 Units]; In Commercial Distribution
GS1	20817170020080 [Package]; Contains: 00817170020086; Package: Inner pack [2 Units]; In Commercial Distribution
GS1	30817170020087 [Package]; Contains: 00817170020086; Package: Case [36 Units]; In Commercial Distribution
GS1	40817170020084 [Package]; Contains: 00817170020086; Package: Case [18 Units]; In Commercial Distribution
GS1	50817170020081 [Package]; Contains: 00817170020086; Package: Inner Pack [1 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: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2017-05-22

Devices Manufactured by INFUTRONIX LLC

• 00817170020376 - Nimbus II EpiD: 2020-09-10 Ambulatory infusion pump
• 20817170020165 - Nimbus II Plus: 2019-03-14 Ambulatory infusion pump
• 00817170020154 - Nimbus: 2019-02-15 This is a plastic box outside a drug bag less than or equal to 100ml.
• 10817170020083 - Nimbus II PainPRO: 2018-10-29Ambulatory infusion pump
• 10817170020083 - Nimbus II PainPRO: 2018-10-29 Ambulatory infusion pump
• 40817170020046 - Nimbus: 2018-07-06 Administration set
• 10817170020090 - Nimbus II Flex: 2018-07-06 Ambulatory infusion pump
• 10817170020106 - Nimbus: 2018-07-06 Ambulaotry infusion pump
• 10817170020007 - Nimbus: 2018-03-29 Ambulatory infusion pump