Y-Piece

GUDID 10627825008201

Laborie Medical Technologies Canada ULC

Infusion controller administration set Infusion controller administration set Electronic gravity infusion controller administration set
Primary Device ID10627825008201
NIH Device Record Key2a8f699d-e172-4317-b5ae-8d69162601b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameY-Piece
Version Model Number9021P1164
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
GS100627825008204 [Primary]
GS110627825008201 [Package]
Contains: 00627825008204
Package: [10 Units]
In Commercial Distribution

FDA Product Code

FENDEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10627825008201]

Ethylene Oxide


[10627825008201]

Ethylene Oxide


[10627825008201]

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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