Profile: Accumedix, Inc. provides small volume manufacturing, assembly, packaging and consulting services to the medical device industry. Our services include manufacturing, packaging, distribution services, obtaining regulatory approvals, regulatory facility registrations, device listings, design control processes, component and raw material procurement, process control, receiving, in-process and final inspections, drop shipping direct to the end user product, design control, prototyping, clinical trial production, validation protocol development, testing and reports. We also provide services such as vendor approval, sourcing, inspection, component stocking with full lot control, assembly, in-process, final quality assurance, project management, oversight to ensure all requirements for a successful project are fulfilled, quality controlled warehousing, quality management representation, regulatory and quality consulting services.
The company is ISO 9001, ISO 13485 certified.
FDA Registration Number: 1424785
3 Products/Services (Click for related suppliers)
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• Contract Manufacturers |
• Contract Manufacturing |
• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use). |