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Laborie Medical Technologies Canada ULC

Last updated May 27, 2026

What Laborie Medical Technologies Canada ULC makes

Laborie Medical Technologies Canada ULC manufactures urodynamic assessment tools, including non-electronic manometric catheters, reusable and single-use pressure monitoring tubing sets, and reusable urine flowmeters. Their portfolio also includes electrically-powered arthroscopic shaver systems, air/gas pressure transducers, and urodynamic measurement systems for bladder function evaluation. Additionally, they produce infusion pump administration sets and general-purpose ultrasound imaging systems for diagnostic imaging.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable medical device compliance standards for these categories.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: laborie.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)522-8743
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 203383526

Catalogue (290)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Air-Charged Reusable Cable	CAB617	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4550V	FDA UDI	Class II	Active
2-lumen Catheter for Abdominal Pressure	9021P4622	FDA UDI	Class II	Active
Pump Tube Set	9021O1226	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, Radiopaque, 12Fr	CATW1B212EX	FDA UDI	Class II	Active
Y-Piece	9021P1164	FDA UDI	Class II	Active
Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 12Fr	CATW1A212EB	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB665	FDA UDI	Class II	Active
Air-Charged ReusableCable	CAB559	FDA UDI	Class II	Active
Air-Trap Tubing	TUB105	FDA UDI	Class II	Active
TDOC Air-Charged 7Fr Single Lumen, Single Sensor Abdominal Catheter	CATT3A17	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, Radiopaque, Short, 6Fr	CATW1B26EXJ	FDA UDI	Class II	Active
2-lumen Cystometry Pack	9021T1101	FDA UDI	Class II	Active
Infusion Pump Tube Set with Dampening Chamber	IPTS-DC-LT2	FDA UDI	Class II	Active
Dual Lumen CMG/UPP Catheter 7F	DLUPP-7D	EUDAMEDFDA UDI	Class II	Active
Two Catheter Set 10F and 4F	FCBP-104	FDA UDI	Class II	Active
Coude Dual Lumen Catheter 9F	CDLC-9D	FDA UDI	Class II	Active
Triple Lumen Catheter 7F Male	TLC-7F	FDA UDI	Class II	Active
Triple Lumen Catheter 9F Male	TLC-9M	FDA UDI	Class II	Active
Cystometry Pack	9021T1031	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB669	FDA UDI	Class II	Active
Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12Fr	CATW1A112B	FDA UDI	Class II	Active
Catheter, Pves, Pura & Vinf, Triple Lumen, Radiopaque, Coude Tip, 7Fr	CATW1B37ECX	FDA UDI	Class II	Active
Peritron	PRN09302	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB667	FDA UDI	Class II	Active
1-lumen Abdominal Pressure Catheter 12 Fr. Latex (400mm)	9021P4222	FDA UDI	Class II	Active
Catheter, Pves, Pura & Vinf, Triple Lumen, Perfusion, 9Fr	CATW1U39ER	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB668	FDA UDI	Class II	Active
Dual Lumen Catheter 6F Pediatric	DLC-6P	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB581	FDA UDI	Class II	Active
Catheter, Vinf only, Single Lumen, 10Fr	CATW1B110	FDA UDI	Class II	Active
NXT Pro Docking Station with Pump	DCX2001	FDA UDI	Class II	Active
Aquarius XT	AQS3000	FDA UDI	Class II	Active
Cystometry Pack	9021T1041	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB666	FDA UDI	Class II	Active
Infusion Sensor	TRA1000	FDA UDI	Class II	Active
1-lumen Catheter	9021P1214	FDA UDI	Class II	Active
Aquarius TT	CAR831	FDA UDI	Class II	Active
Extension Line	9021P6341	FDA UDI	Class II	Active
Extension Set 2	9021P1283	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4023U	FDA UDI	Class II	Active
4-Way Stop Cock	4-SCA	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4550U	FDA UDI	Class II	Active
NXT Go Infusion Hook	MSM1185	FDA UDI	Class II	Active
Tubing, Extension Line, Clear, 150 cm	TUBEX1C	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4530P4	FDA UDI	Class II	Active
Perfusion Set 2	9021P6022	FDA UDI	Class II	Active
1-lumen Catheter for Abdominal Pressure	9021P4522	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry and Urethral	9021P5102	FDA UDI	Class II	Active
Aquarius TT with Evox	PRO177	FDA UDI	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Laborie Medical Technologies Canada ULC has one recall record initiated on 2020-04-22, which is listed with a terminated status. The recall was prompted by a field correction to address potentially damaged seals in the packaging of some Pump Tube Sets, where inventory was found to have breaches or folds in the seals.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 22, 2020	Z-2535-2020	—	terminated	This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Finished goods inventory was detected with damage to their seals in the form of breaches or folds. Based on our investigation the issue appears to be limited to a single lot of part number 902101226 pump tubing sets.