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spectrum

Tucson, AZ

4700 S. Overland Drive
Tucson, AZ 85714
Phone: (520) 882-7794

Xeridiem Medical Devices was acquired in 2016 under Kelpac Medical. This operation features our silicone tubing, silicone molding (both LIM and compression) and finished device product lines. With extensive engineering resources and material expertise, products such as feeding tubes, extension sets, chest tubes, and catheters are designed, assembled, and FDA registered in house.

Markets
Enteral Feeding
Urology
Silicone Components
EP Catheters
Cardiology

Square Footage
48,000 square feet

Machinery
2 silicone extruders
11 silicone molders (4 liquid silicone LIM/LSR)

Methods
Silicone tube extrusion
Silicone Molding
Assembly
Regulatory Management
Sterilization Management

Certified to or complies with the following: 

  • EN ISO 13485 : 2016 (click link to view document), Medical Devices – Quality management systems – Requirements for regulatory purposes
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD), as amended
  • Regulation (EU) 2017/745,  medical devices
  • Australia - Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure.
  • Brazil - RDC ANVISA n. 16/2013 RDC ANVISA n. 23/2012 RDC ANVISA n. 67/2009
  • Canada - Medical Devices Regulations (CMDR) – Part 1- SOR 98/282
  • Japan - MHLW Ministerial Ordinance 169, Article 4 to Article 68, PMD Act (as applicable)
  • United States – 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D, 21 CFR 820 – Quality System Regulation
  • ISO 14971:2012, Medial Devices – Application of Risk Management to Medical Devices

Team Up

Finishing the job

Spectrum Plastics Group evolves from component manufacturer to finished device contract injection molder. 
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