FDA Registration
Active
🇺🇸 United States
Xeridiem Medical Devices
Reg #: 2025851
·
FEI: 2025851
·
Expires 2026
Products
12
Proprietary Names
16
Establishment Types
5
Classifications
12
Registration Details
- Registration Name
- Xeridiem Medical Devices
- Registration Number
- 2025851
- FEI Number
- 2025851
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4700 S Overland Dr
- City
- Tucson
- State
- AZ
- ZIP
- 85714
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142297
Owner / Operator
- Firm Name
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Operator Number
- 2025851
- Address
- 4700 SOUTH OVERLAND DR., --
- City
- Tucson
- State
- AZ
- Postal Code
- 85714
- Country
- US
- Correspondent
- Adin Potter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | OCM | Class 3 | Unknown | No | 2023-12-22 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2015-01-12 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2017-10-12 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2017-11-01 |
| Wound Drain Catheter System | OTK | Class 2 | General, Plastic Surgery | No | 2017-11-01 |
| Tube, Nasogastric | BSS | Class 2 | Gastroenterology, Urology | No | 2019-10-11 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-10-14 |
| Intrauterine Tamponade Balloon | OQY | Class 2 | Obstetrics/Gynecology | No | 2020-10-14 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2013-01-29 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2020-10-14 |
| Catheter, Upper Urinary Tract | EYC | Class 2 | Gastroenterology, Urology | No | 2019-10-11 |
| System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | MEQ | Class 3 | Unknown | No | 2013-01-29 |
Proprietary Names
EndoVive 3s Low Profile Balloon Kit
EndoVive 3s Medication Extension Sets
EndoVive 3s Continuous Extension Sets
EndoVive 3s Bolus Extension Sets
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit connector; Entuit Gastrostomy BR Balloon Retention Feeding
PleuraFlow System With FlowGlide
EntuitTM Thrive Balloon Retention Gastrostomy Feeding Tube
EndoVive
Moss Nasal tube
Moss Gastrostomy Tube
MACY CATHETER
PleuraFlow System with FlowGlide Extra Drainage Length
PleuraFlow System with FlowGlide
Smiths-Level 1 Foley Catheter with Temperature Sensor
Foley Catheter with Temperature Sensor
ProstaLund-CoreTherm Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Reprocess Single-Use Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device