PIM NXT for eSense

GUDID 08720648846069

Laborie Medical Technologies Corp.

Urodynamic measurement system
Primary Device ID08720648846069
NIH Device Record Keya0fe2190-37f4-414b-9757-9dbd300decf8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIM NXT for eSense
Version Model NumberPIX7000
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
GS108720648846069 [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 Date2025-03-03
Device Publish Date2025-02-21

Devices Manufactured by Laborie Medical Technologies Corp.

00627825014823 - SOLAR Anorectal Manometry Charger2025-03-14 SOLAR Anorectal Manometry Charger
10627825014837 - SOLAR Anorectal Manometry Catheter2025-03-14 SOLAR Anorectal Manometry Catheter
08720648846052 - SOLAR Compact2025-03-14 SOLAR Compact
08720648846069 - PIM NXT for eSense2025-03-03
08720648846069 - PIM NXT for eSense2025-03-03
00627825013529 - e•Sense 7Fr Single Sensor Bladder Catheter2024-12-20 e•Sense 7Fr Single Sensor Bladder Catheter
10627825013533 - e•Sense 7Fr Single Sensor Coudé Bladder Catheter2024-12-20 e•Sense 7Fr Single Sensor Coudé Bladder Catheter
10627825013540 - e•Sense 7Fr Dual Sensor Urethral Catheter2024-12-20 e•Sense 7Fr Dual Sensor Urethral Catheter
00627825013550 - e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter2024-12-20 e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.