FDA Registration Active 🇺🇸 United States

Air-Charged Catheters

Reg #: 3017448360 · FEI: 3017448360 · Expires 2025
Products
1
Proprietary Names
17
Establishment Types
4
Classifications
1

Registration Details

Registration Name
LABORIE MEDICAL TECHNOLOGIES CORP.
Registration Number
3017448360
FEI Number
3017448360
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
180 International Drive
City
Portsmouth
State
NH
ZIP
03801
Country
US

Owner / Operator

Firm Name
Laborie Medical Technologies Corp.
Operator Number
10079684
Address
180 International Drive
City
Portsmouth
State
NH
Postal Code
03801
Country
US
Correspondent
Nicole Boser

Products

Device Name Product Code
Device, Cystometric, Hydraulic FEN

Proprietary Names

Air-Charged Catheters Electrodes T-DOC Air-Charged Dual Sensor Catheter T-DOC Air-Charged Single Sensor Catheter Abdominal Pressure Catheter T-DOC Air-Charged Abdominal Sensor Catheter T-DOC Air-Charged Catheter Pump Tubing Infusion Line Coude Dual Lumen Catheter Infusion Pump Tube Set Air-Charged Reusable Cable Cystometry Pack Bladder Pressure Catheter Urodynamic Measurement Tubing Urodynamic Catheters Solar Blue, Nexam e•Sense® Urodynamic Catheters

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198