Home GUDID E261UDAELN0 Atmos
Primary DI E261UDAELN0
Brand Atmos
Company BIOENGINEERING LABORATORIES SRL
Model UD-AELN
Device description Transparent extension line 1500mm
Published 2024-09-03
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name EXQ Cystometer, Electrical Recording
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EXQ Cystometer, Electrical Recording Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E261UDAELN1 Package HIBCC 50 Not in Commercial Distribution E261UDAELN2 Package HIBCC 2 Not in Commercial Distribution E261UDAELN0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Urological pressure monitoring tubing set A collection of devices that includes the tubing and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used as an external connection for the invasive measurement of urethral and related urological pressures. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 1500 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 5 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 447644969 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00890477000395 Tri-Electrode Surface EMG SRS Medical Systems, Inc. EXQ 2026-03-04 00089047700395 Tri-Electrode Surface EMG SRS Medical Systems, Inc. EXQ 2026-03-04 00890477000371 EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) SRS Medical Systems, Inc. EXQ 2026-01-21 00890477000388 EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) SRS Medical Systems, Inc. EXQ 2026-01-21 00086000980061 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800601 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800625 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800632 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800649 Glean Bright Uro, Inc EXQ 2025-09-23 00860009800656 Glean Bright Uro, Inc EXQ 2025-09-23 08032248487123 Atmos DELTA MED SPA EXQ 2025-09-02 08032248487147 Atmos DELTA MED SPA EXQ 2025-09-02 08032248487185 Infusion Set DELTA MED SPA EXQ 2025-09-02 08032248490130 Atmos DELTA MED SPA EXQ 2025-09-02 38032248487124 Atmos DELTA MED SPA EXQ 2025-09-02 08032248487130 Atmos DELTA MED SPA EXQ 2025-09-02 38032248487148 Atmos DELTA MED SPA EXQ 2025-09-02 38032248487186 Infusion Set DELTA MED SPA EXQ 2025-09-02 38032248490131 Atmos DELTA MED SPA EXQ 2025-09-02 E261MMT11730 Infusion Set BIOENGINEERING LABORATORIES SRL EXQ 2024-12-09 E261MMT11731 Infusion Set BIOENGINEERING LABORATORIES SRL EXQ 2024-12-09 E261UDA462150 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-10-10 E261UDA462151 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-10-10 08720648846083 Flowsensor3-BT Medical Measurement Systems B.V. EXQ 2024-09-17 E261UDA582450 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-09-03 E261UDA582451 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-09-03 E261UDAELN1 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-09-03 E261UDA362050 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-09-02 E261UDA362051 Atmos BIOENGINEERING LABORATORIES SRL EXQ 2024-09-02 18717775955556 Flowstar NS Medical Measurement Systems B.V. EXQ 2024-05-24