TDOC Air-Charged 7Fr Single Lumen, Single Sensor Abdominal Catheter

GUDID 20627825011116

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic
Primary Device ID20627825011116
NIH Device Record Keydd3de960-af50-4f50-8399-c5cfea14de08
Commercial Distribution StatusIn Commercial Distribution
Brand NameTDOC Air-Charged 7Fr Single Lumen, Single Sensor Abdominal Catheter
Version Model NumberCATT3A17
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627825011112 [Primary]
GS110627825011119 [Package]
Contains: 00627825011112
Package: [10 Units]
In Commercial Distribution
GS120627825011116 [Package]
Contains: 10627825011119
Package: [10 Units]
In Commercial Distribution

FDA Product Code

FENDevice, Cystometric, Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-28
Device Publish Date2018-12-27

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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