Infusion Pump Tube Set

GUDID 10627825000045

Laborie Medical Technologies Canada ULC

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use
Primary Device ID10627825000045
NIH Device Record Key12e026df-5bb3-448f-afe2-342524ec88ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfusion Pump Tube Set
Version Model NumberIPTSA-LT1
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
GS100627825000048 [Primary]
GS110627825000045 [Package]
Contains: 00627825000048
Package: [25 Units]
In Commercial Distribution
GS120627825000042 [Package]
Package: [200 Units]
In Commercial Distribution

FDA Product Code

FENDEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10627825000045]

Ethylene Oxide


[10627825000045]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [Infusion Pump Tube Set]

20627825000059IPTSA-LT2
10627825000045IPTSA-LT1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.