Complete Starter Kit.

Feature Specification
Dose range: 1–60 units
Dose increment: 1 unit
Cartridge size: 3 mL (100 IU/mL)
Compatible insulin: Humalog®, Huminsulin®
Mechanism: Mechanical piston syringe
Needles: Standard detachable pen needles
Regulatory clearance: FDA 510(k) K151686
Whats in the Box ?
1. Ergo Pen II ( Pens may Vary according to supply)
2. Portable carry case which holds pen, three needles, two -3ml Vials
3. X four 3ML HTC Sterile Vials (57mmx130mm)
4.  x three scew on sterile disposible needles (0.23x4mm)

📌 Device Classification & Regulatory Details

Device name: Ergo Pen II

Manufacturer: Either = Eli Lilly® and Company, Humalog® & Huminsulin® depending on supply.

Regulatory class: Class II piston‑syringe device

FDA clearance: 510(k) K151686 (cleared 30 Dec 2015)

⚙️ Mechanical & Functional Specifications
Dose Delivery

Dose range: 1 to 60 units per injection

Dose increments: 1‑unit steps (fully adjustable)

Over‑dial protection: If you dial too high, you can dial back without wasting insulin

Injection mechanism: Manual mechanical piston drive (no electronics)

Cartridge Compatibility

Compatible cartridges:

Humalog® 3 mL (100 IU/mL)

Huminsulin® 3 mL (100 IU/mL)

Other Lilly 3 mL cartridges depending on region

Source: Official user manual

Cartridge holder: Screw‑type attachment for secure seating

Needle Compatibility

Uses single‑use, detachable pen needles (not included)

Compatible with standard pen‑needle brands (e.g., BD Viva® per NHS device guide)

Pen Construction & Components
From the official manual diagram:

Pen body

Dose knob

Injection button

Cartridge holder

Plunger

Inner & outer needle caps

Rubber cartridge cap seal

Paper tab (needle)

Designed for ergonomic grip and repeatable mechanical dosing.

📏 Physical & Usability Features

Reusable lifespan: Long‑term mechanical use (no electronics to expire)

Colour variants: Multiple colours depending on region (functionally identical)

Ergonomic design: Shaped for stable grip and low‑force dose dialing

Reset mechanism: Automatic plunger reset when inserting a new cartridge

Safety: No insulin exposure during cartridge change

🧪 Intended Use

Self‑injection of insulin using Lilly 3 mL cartridges

Suitable for adults and children with proper training

Designed for home and clinical use