Xeridiem Medical Devices, A Spectrum Plastics Group Company
Country not established
- Devices
- 2
What Xeridiem Medical Devices, A Spectrum Plastics Group Company makes
Xeridiem Medical Devices manufactures low-profile balloon retention gastrostomy feeding tubes, patient care kits (including ENFit-connected versions), and associated feeding sets for bolus and continuous nutrition delivery. Products include the Entuit LP series for gastrostomy feeding and the Kangaroo line for balloon gastrostomy procedures, designed for long-term enteral nutrition support.
The company’s portfolio is regulated under FDA Class II devices and authorised via 510(k) clearances. These products are listed in the FDA’s 510(k) database and comply with US regulatory requirements for medical devices. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xeridiem Medical Devices, A Spectrum Plastics Group Company have in the registry?
The registry currently lists 2 devices for Xeridiem Medical Devices, A Spectrum Plastics Group Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xeridiem Medical Devices, A Spectrum Plastics Group Company's devices?
Among its 2 most recently registered devices, Xeridiem Medical Devices, A Spectrum Plastics Group Company has devices listed in FDA 510(k) (2 devices).
What risk classes do Xeridiem Medical Devices, A Spectrum Plastics Group Company's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Xeridiem Medical Devices, A Spectrum Plastics Group Company's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xeridiem Medical Devices, A Spectrum Plastics Group Company in the registry?
The most recently registered devices listed for Xeridiem Medical Devices, A Spectrum Plastics Group Company include Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit and Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection.