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 Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump 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

Trademark Results [Nimbus]

Mark Image Registration \| Serial	Company Trademark Application Date
NIMBUS 98455972 not registered Live/Pending	Nimbus Nordic A/S 2024-03-19
NIMBUS 98376576 not registered Live/Pending	UBIIK INC. 2024-01-26
NIMBUS 97835974 not registered Live/Pending	Nimbus Motorcycles Danmark A/S 2023-03-13
NIMBUS 97541638 not registered Live/Pending	Smisek, Wayne 2022-08-09
NIMBUS 97539260 not registered Live/Pending	Entropy Technology Design, Inc. 2022-08-08
NIMBUS 97341759 not registered Live/Pending	Nimbus Healthcare Corporation 2022-03-31
NIMBUS 97134051 not registered Live/Pending	Presidential Garden Group Inc. 2021-11-19
NIMBUS 97134049 not registered Live/Pending	Presidential Garden Group Inc. 2021-11-19
NIMBUS 97134046 not registered Live/Pending	Presidential Garden Group Inc. 2021-11-19
NIMBUS 90864923 not registered Live/Pending	McCoy Global Inc. 2021-08-04
NIMBUS 90833983 not registered Live/Pending	Shakuff LLC 2021-07-16
NIMBUS 90756208 not registered Live/Pending	Capital One Financial Corporation 2021-06-04