FDA-Cleared 510(k) Reusable 80 Unit Injection Pen
FDA-Cleared 510(k) Reusable 80 Unit Injection Pen
(6 customer reviews)FDA-Cleared 510(k) Reusable 80 Unit Injection Pen
FDA-cleared precision dosing device for injectable medications. Delivers 0-80 units in 0.01mL increments with audible click confirmation. Ergonomic design, universal 3mL cartridge compatibility.
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FDA 510(k) Cleared Medical Device for Precision Delivery
Product Overview
The Reusable 80 Unit Injection Pen is an FDA-cleared medical device designed for precise, convenient self-administration of injectable medications. This durable pen system provides accurate dosing for patients requiring regular injections.
Manufactured by Nest Scientific USA.
Key Features
FDA Cleared & Certified
- FDA 510(k): K240774
- ISO 13485 certified manufacturing
- CE MDR compliant
- Meets YY/T 1768.1-2021 international standards
Precision Dosing
- Up to 80 units in 0.01mL increments
- ±5% accuracy validated across multiple conditions
- Clear dose window with easy-to-read markings
- Audible click confirmation for each unit
Universal Compatibility
- Standard 3mL cartridge system
- Compatible with universal pen needles (sold separately)
- Suitable for various injectable medications as prescribed
User-Friendly Design
- Ergonomic grip for comfortable handling
- Lightweight, balanced construction
- Simple cartridge replacement
Quality & Safety
- Low pressing force: <5N at 36–37 units, <8N at 74–80 units
- Drop-tested and vibration-tested
- Reusable pen rated for 3,000 injection cycles
- 5-year shelf life
- Cleanroom manufactured (ISO Class 7/8)
Technical Specifications
- Dose Range: 0-80 units (0.8mL max)
- Minimum Increment: 0.01mL
- Cartridge Size: 3mL standard
- Storage: 10-30°C, <80% RH
- Materials: Medical-grade polymers (ROHS/REACH compliant)
Package Contents
- 1 Reusable Pen Injector
- 1 Durable carrying case
- User manual
- Needles and medication cartridges sold separately
Customer Reviews (6)
Much better than generic injectors. Easy to fill, easy to use - great!
Pretty great, overall. Unclear on how the volume dispensing works, it just 1, 2, 3, etc., but not sure what that represents. CC?
Have not tried the pen yet. But I will comment on the packaging and the drop off. Fast and easy. Superb service from them and fast communication as well. I will buy more for sure.
works perfectly
Very quick delivery and works great!