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Immucise™
PHARMACEUTICAL

Description

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Immucise™ Intradermal Injection System is designed to deliver vaccines and other approved drugs to the dermal layer of the skin. The vertical type intradermal (ID) injection system is applied perpendicular to the skin of the deltoid region of the patient’s armᶦᶦᶦ. The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.

Characteristics

Immucise™ Intradermal Injection System is designed to deliver vaccines and other approved drugs to the dermal layer of the skin. The Immucise™ needle has an outer diameter of 0.2 mm (33G), length of 1.15 mm, and bevel length of 0.6 mmᶦᶦᶦ. The limiter ring guides the needle for perpendicular insertion into the patient’s deltoid region of the armᶦᵛ. The flange is designed to guide proper pressure against the skinᶦᶦᶦ.

Please always consult the product label and instructions for use (IFU) for a complete overview of the instructions for use, warnings, cautions and precautions prior to actual use.

Immucise™ Intradermal Injection Needle Product Features

  • Stainless steel needle 33G (0.2 mm OD)
  • Exposed needle length 1.15 mm
  • Needle bevel 0.6 mm

Regulatory Status

  • CE Marking (EU)
  • 510(k) Clearance and Device Listing (United States)
  • PMDA Registration (Japan)

Preparation


General Specifications

Immucise™ Intradermal Injection System
(Immucise™ Intradermal Injection Needle and Immucise™ Syringe)


Specification Description
Needle Stainless steel
Needle Gauge 33G
Exposed Needle Length 1.15 mm
Bevel Length 0.6 mm
Needle Dead Volume < 8 µlᶦᶦ
Connection Luer Lock
Flange, Limiter Ring Material & needle hub Polypropylene
Sterility Electron Beam (E-Beam)

Link to public Studies

1. Sakiko Shimizu, Ryo Tanaka, Eriko Itoh, Minami Maekawa-Matsuura, Yoichiro Iwase, Performance and usability evaluation of novel intradermal injection device Immucise™ and reanalysis of intradermal administration trials of influenza vaccine for the elderly, Vaccine, Volume 40, Issue 6, 7 February 2022, Pages 873-879
https://www.sciencedirect.com/science/article/pii/S0264410X21016698?via%3Dihub_

2. Ryo Arakane, Hitomi Nakatani, Emi Fujisaki, Akiko Takahama, Katsuyasu Ishida, Michiharu Yoshiike, Tetsuo Nakayama, Fumihiko Takeshita, Immunogenicity and safety of the new intradermal influenza vaccine in adults and elderly: A randomized phase 1/2 clinical trial, Vaccine, Volume 33, Issue 46, 17 November 2015, Pages 6340-6350,
https://www.sciencedirect.com/science/article/pii/S0264410X15012566?via%3Dihub

Downloads

Relevant product information
Terumo Immucise™ Intradermal Injection System Brochure.pdf

References

ᶦ Intradermal Delivery of Vaccines, A review of the literature and the potential for development for use in low- and middle income countries, August 27, 2009

ᶦᶦ Internal Company data

ᶦᶦᶦ Shimizu, Sakiko et al. “Performance and usability evaluation of novel intradermal injection device Immucise™ and reanalysis of intradermal administration trials of influenza vaccine for the elderly.” Vaccine vol. 40,6 (2022): 873-879

ᶦᵛ Traditional 510(k) – Immucise Intradermal Injection System Section 11: Device Description


Disclaimers

This intradermal injection system is manufactured for clinical trials and/or studies of specific pharmaceutical and/or medicinal products only. Its specifications and/or images may be changed without notice, even if the device has been approved and/or registered in specific countries and/or regions. Notwithstanding any existing approval or registration, this device may not be available in all geographic regions. For further detail please refer to instruction for use or check with contact person in Terumo Corporation.

The contents herein may contain information which is protected by intellectual property rights owned by Terumo Corporation. Any use of the information contained herein (including, but not limited to, total or partial reproduction, communication or distribution in any form) by entities other than the designated entities is prohibited.

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