Atmos

GUDID E261UDAELN1

Transparent extension line 1500mm

BIOENGINEERING LABORATORIES SRL

Urological pressure monitoring tubing set

• Primary Device ID: E261UDAELN1
• NIH Device Record Key: a77a6c49-2601-474a-88ac-970e540f9c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atmos
• Version Model Number: UD-AELN
• Company DUNS: 447644969
• Company Name: BIOENGINEERING LABORATORIES SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter
• Length: 1500 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E261UDAELN0 [Primary]
HIBCC	E261UDAELN1 [Package]; Contains: E261UDAELN0; Package: Shelf Box [50 Units]; In Commercial Distribution
HIBCC	E261UDAELN2 [Package]; Package: Shipping Carton [2 Units]; In Commercial Distribution

FDA Product Code

• EXQ: Cystometer, Electrical Recording

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-09-03

On-Brand Devices [Atmos]

• E261UDA362051: Pump Tubing 3,2 x 6,4
• E261UDAELN1: Transparent extension line 1500mm
• E261UDA582451: Pump Tubing 5x8mm
• E261UDA462151: Pump Tubing 4x6mm