Nimbus II Plus

Basic Information

• Brand Name: Nimbus II Plus
• Primary DI: 00817170020161
• Version / Model: Nimbus II Plus
• Company Name: INFUTRONIX LLC
• Labeler DUNS: 079821136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-06
• Public Version: 3
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 5ad87494-33f8-4cc2-a702-f2f7fa9d98ce

Device Description

Ambulatory infusion pump

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEA	Pump, Infusion, Pca	General Hospital	880.5725	2
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35932	Patient-controlled analgesia infusion pump	A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.	No	Obsolete
61514	Ambulatory non-insulin infusion pump, electronic	A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller, and is used with a dedicated single-use medication cartridge (not included). It is used with a suitable injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be worn by the patient within and outside healthcare settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817170020165	GS1	Case	60	In Commercial Distribution
Primary	00817170020161	GS1
Package	10817170020168	GS1	Inner Pack	1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K153193	000