NXT

GUDID 00627825011648

NXT Evo

Laborie Medical Technologies Corp.

Urodynamic measurement system
Primary Device ID00627825011648
NIH Device Record Key285f03c9-acc0-4c90-8caa-a2b320775f88
Commercial Distribution StatusIn Commercial Distribution
Brand NameNXT
Version Model NumberNXT2400
Company DUNS117783313
Company NameLaborie Medical Technologies Corp.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627825011648 [Primary]

FDA Product Code

FENDevice, Cystometric, Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-15
Device Publish Date2022-11-07

On-Brand Devices [NXT]

00627825011648NXT Evo
00627825011631NXT Go with Cart
00627825002059Cable, AC, Laborie
00627825002042Cable, AC, Laborie NXT, Binder 8 pin P4
00627825002035Cable, AC, Laborie NXT, Binder 8 pin P-Ura
00627825002028Cable, AC, Laborie NXT, Binder 8 pin P-Ves
00627825002011Cable, AC, Laborie NXT, Binder 8 pin P-Abd

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