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Animas
Summary: The Model r1000 IR Insulin Pump by Animas is a medical device used for insulin delivery in patients with diabetes. It is typically used by endocrinologists and diabetes specialists to manage blood glucose levels.
FDA Clearance Information
Pathway
510K
Number
K021439 ↗
Decision Date
May 29, 2002
Product Code
LZG
Device Class
Class 2
Evidence
0 studies
The Model r1000 IR Insulin Pump was cleared through the FDA 510k pathway on May 29, 2002. Manufactured by Animas, it is classified as a Class 2 device under product code LZG.
What It Is
The Model r1000 IR Insulin Pump is a portable device designed to deliver insulin to patients with diabetes. It works by providing continuous subcutaneous insulin infusion, allowing for precise control of blood glucose levels. The device includes software for programming insulin delivery and a cradle for downloading data, which helps in managing and adjusting treatment plans.
Clinical Applications
This insulin pump is commonly used in outpatient settings by endocrinologists and diabetes specialists. It is suitable for patients with type 1 diabetes who require intensive insulin therapy and prefer a more flexible lifestyle. The device is also used in hospital settings for patients who need continuous insulin delivery during their stay.
Indications for Use
The FDA-cleared indications for this device include its use in patients with diabetes who require insulin therapy. It is particularly beneficial for those needing precise and adjustable insulin dosing.
Practical Considerations
The Model r1000 IR Insulin Pump is compatible with various insulin types and infusion sets. Clinicians should ensure proper training for patients on device operation and maintenance. Regular monitoring of infusion sites is recommended to prevent complications.
Frequently Asked Questions
What is the Model r1000 IR Insulin Pump used for?
It is used for delivering insulin to patients with diabetes to help manage blood glucose levels.
What specialties typically use this device?
Endocrinologists and diabetes specialists typically use this device in both outpatient and inpatient settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with diabetes who require insulin therapy, allowing for precise and adjustable insulin dosing.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.