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K-Pack Embrace™ Active Safety Needle
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Safety Needles
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K-Pack Embrace™ Active Safety Needles from Terumo Medical Care Solutions - Pharmaceutical Solutions Division are hypodermic injection needles individually packed in a compact hard protective case, designed to help maintain needle integrity throughout automated co-packing processes. The device incorporates an integrated safety shield designed to help reduce the risk of accidental needle stick injuries for lay users and healthcare professionals (HCPs). K-Pack Embrace™ Active Safety Needle applies our Deviceuticals™ framework, which focuses on bringing together administration devices and pharmaceutical products. KPack Embrace™ Active Safety Needle combines an integrated needle safety feature, protective packaging and downstream process readiness, supporting efficient co-packing with drug products.
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Description
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Characteristics
Characteristics
General-Specifications
Specifications
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Downloads
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References
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Product Images
K-Pack Embrace™ Active Safety Needle Images
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Characteristics
K-Pack Embrace™ Active Safety Needle
The K-Pack Embrace™ Active Safety Needle is packed in a hard case designed to enable automated co-packing. The sealed rigid cap and case are designed to help maintain needle integrity during normal handling, transport and storage, while helping to maintain product sterility throughout the product’s shelf life. The hypodermic needle with safety shield is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. After use, the safety shield shall be manually locked to cover the needle to reduce the risk of accidental needle stick injuries (NSIs).
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Designed for Automated Downstream Co-Packing Processes
- Individually packed in a hard plastic case designed for automated needle handling
- Color-coded label with 2D barcode (UDI carrier) designed to support in-line visual inspection
- Tamper-evident label on the hard case and cap provides visual evidence of whether the primary packaging has been previously opened.
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Integrated Needle Safety Features
- After use, the safety shield is used to cover the needle, helping to reduce the risk of accidental needle stick injuries (NSIs)
- The integrated safety shield built into the K-Pack Embrace™ Active Safety Needle can be locked with one hand using the index finger, thumb or surface activation
- Locking of the safety shield is verified by audible/or tactile "click"
- The design features of the K-Pack Embrace Active Safety Needle are compliant with ISO 23908
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Range of Safety Injection Needle Options Available
- Two 25G safety needle options are available with 1" (25 mm) and 5/8" (16 mm) cannula lengths and needle diameter of 0.5 mm
- T-Sharp™ lancet technology and silicone needle coating
- Intended for all standar routes of administration for parenteral medication – subcutaneous (SC), intramuscular (IM) and intravenous (IV) applications
- Compatible with standard ISO 80269-7 Luer slip and Luer lock syringes
- Additional needle gauges and lengths will become available in the future
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K-Pack Embrace™ Active Safety Needle Regulatory Status and Quality Details
- Sterilization by Ethylene Oxide (EtO) to achieve Sterility Assurance Level (SAL) of at least 10-6
- In compliance with applicable ISO standards and Pharmacopoeia
- CE marked in accordance with Regulation (EU) 2017/745 (MDR).
Conformity assessment performed by TÜV Rheinland LGA Products GmbH, Germany (NB 0197) - U.S. Food and Drug Administration (U.S. FDA) 510(k)-cleared
- Licensed by Health Canada
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General Specifications
Specifications for K-Pack Embrace™ Active Safety Needle
K-Pack Embrace™ Active Safety Needles are intended for subcutaneous (SC), intramuscular (IM) and intravenous (IV) applications and include T-Sharp™ technology with safety features packed in a sealed hard protective case.
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Discover Deviceuticals™
K-Pack Embrace™ Active Safety Needle demonstrates how Deviceuticals™ brings together technologies, platforms and expertise to create integrated pharmaceutical solutions that support the entire drug delivery journey.
Explore the Deviceuticals™ Framework
Explore our Injection Device Platform
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Global Solutions for
K-Pack Embrace™ Active Safety Needle
K-Pack Embrace ™ Active Safety Needles are available to drug product manufacturers in registered countries. For more information about product availability, specifications and applicable standards, download our data sheet or contact Terumo Pharmaceutical Solutions Division.
Please note that some products may not be available in all regions, reach out to your local Terumo Pharmaceutical Solutions Pharmaceutical Contact for details. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.
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Downloads
K-Pack Embrace™ Active Safety Needle Information
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Product Brochure
Download Brochure
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Related Products
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K-Pack™II Needles
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SurGuard™3 Safety Hypodermic Needle
View All Injection Needles
View All Injection Needles
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Contact
Connect with Our Experts for Tailored Support
We are here to help. For more information about our K-Pack™II Needles product availability, specifications, and applicable standards, download our data sheet or contact your Terumo Pharmaceutical Solutions representative today.
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