Urodynamics Measurement Tubing

GUDID 20627825000066

Laborie Medical Technologies Canada ULC

Urological pressure monitoring tubing set Urological pressure monitoring tubing set
Primary Device ID20627825000066
NIH Device Record Key716b0137-e4cf-4d21-b82d-e6ae62e9bdc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUrodynamics Measurement Tubing
Version Model NumberTUB101
Company DUNS203383526
Company NameLaborie Medical Technologies Canada ULC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627825000062 [Primary]
GS110627825000069 [Package]
Contains: 00627825000062
Package: [25 Units]
In Commercial Distribution
GS120627825000066 [Package]
Contains: 10627825000069
Package: [200 Units]
In Commercial Distribution

FDA Product Code

FENDEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20627825000066]

Ethylene Oxide


[20627825000066]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

Devices Manufactured by Laborie Medical Technologies Canada ULC

30627825007024 - Extension Set 22022-07-04
20627825007294 - Extension Line, 60 cm2022-07-04
20627825007317 - Extension Line, 1500mm2022-07-04
20627825007324 - Extension Line, 15cm2022-07-04
20627825007348 - Extension Line, 150cm Blue2022-07-04
30627825007352 - Extension Line, 150cm Yellow2022-07-04
20627825007034 - Extension Set 32022-07-04
30627825007307 - Extension Line, 90 cm2022-07-04

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