FDA.reportPublic FDA data

Tubing, Infusion Pump for Laborie Systems

Primary DI
10627825010273
Brand
Tubing, Infusion Pump for Laborie Systems
Company
Laborie Medical Technologies Canada ULC
Model
TUBPTLAB
Published
2017-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FENDEVICE, CYSTOMETRIC, HYDRAULIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20627825010270PackageGS120In Commercial Distribution
30627825010277PackageGS140In Commercial Distribution
10627825010273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2062782501027020627825010270
3062782501027730627825010277
1062782501027310627825010273

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
203383526
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627825000031Pump Tubing Infusion LineTUB5002016-09-21
00627825011013Probe, Manometry, Vaginal SensorPRB1132017-09-01
00627825011020Probe, Manometry, Anal SensorPRB1082017-09-01
00627825011037Tube for Anal Sensor, with 3-way StopcockPRB0782017-09-01
00627825011044Tube for Vaginal Sensor, with 3-way StopcockPRB0802017-09-01
00627825000109ITAITA2016-09-21
00627825008204Y-Piece9021P11642016-09-21
10627825007020Extension Set 29021P12832016-09-21
10627825007297Extension Line, 60 cm9021P63122016-09-21
10627825007310Extension Line, 1500mm9021P63322016-09-21
10627825007327Extension Line, 15cm9021P63512016-09-21
10627825007341Extension Line, 150cm Blue9021P63712016-09-21
10627825007358Extension Line, 150cm Yellow9021P63812016-09-21
10627825008294Extension Set 39021P12932016-09-21
10627825008386Extension Line, 90 cm9021P63222016-09-21
10627825008393Extension Line, 150cm Red9021P63612016-09-21
10627825010358Tubing, Extension Line, Clear, with Stopcock, 150 cmTUBEX1CS2017-10-01
10627825010365Tubing, Extension Line, Clear, 150 cmTUBEX1C2017-10-01
10627825010372Tubing, Extension Line, Blue for Pves, 150 cmTUBEX1B2017-10-01
10627825010389Tubing, Extension Line, Red for Pabd, 150 cmTUBEX1R2017-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248471030Securmeter Foley ManometerDELTA MED SPAFEN2025-05-19
10627825014844T-DOC 5Fr Air-Charged Abdominal Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825014851T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825014868T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
006278250005742-Way Stop CockLaborie Medical Technologies Canada ULCFEN2020-10-02
006278250005814-Way Stop CockLaborie Medical Technologies Canada ULCFEN2020-10-02
10627825010433Catheter, Pabd, Dual Lumen, Closed Balloon, Latex, 12FrLaborie Medical Technologies Canada ULCFEN2017-11-01
10627825010280Tubing, Infusion Pump for MMS Solar SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010297Tubing, Infusion Pump for MMS Solar Systems, with spikesLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010303Tubing, Infusion Pump for MMS Solar Systems, with chamberLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010310Tubing, Infusion Pump for MMS Nexam NPU SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010327Tubing, Infusion Pump for Andromeda SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010334Tubing, Infusion Pump for Mediwatch SystemsLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010358Tubing, Extension Line, Clear, with Stopcock, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010365Tubing, Extension Line, Clear, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010372Tubing, Extension Line, Blue for Pves, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010389Tubing, Extension Line, Red for Pabd, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010396Tubing, Extension Line, Yellow for Pura, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010402Tubing, Extension Line, 2 Set, Blue/Red, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010419Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cmLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010426Pump Guard / Dampening chamberLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010440Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010457Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 9FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010464Catheter, Pabd, Single Lumen, Closed Balloon, Latex, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010471Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010488Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010495Catheter, Pabd, Single Lumen, Split Balloon, PVC, 4.5FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010501Catheter, Pves & Vinf, Dual Lumen, 6FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010518Catheter, Pves & Vinf, Dual Lumen, 8FrLaborie Medical Technologies Canada ULCFEN2017-10-01
10627825010525Catheter, Pves & Vinf, Dual Lumen, 10FrLaborie Medical Technologies Canada ULCFEN2017-10-01