Infusion Set

GUDID E261MMT11731

Pump Tubing 4x6mm

BIOENGINEERING LABORATORIES SRL

Urological irrigation set

• Primary Device ID: E261MMT11731
• NIH Device Record Key: d64d1249-096f-4966-9025-de0227b57267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infusion Set
• Version Model Number: MMT1173
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E261MMT11730 [Primary]
HIBCC	E261MMT11731 [Package]; Contains: E261MMT11730; Package: Shelf Box [25 Units]; In Commercial Distribution
HIBCC	E261MMT11732 [Package]; Package: Shipping box [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: 2024-12-17
• Device Publish Date: 2024-12-09

Devices Manufactured by BIOENGINEERING LABORATORIES SRL

• E261MMT11731 - Infusion Set: 2024-12-17Pump Tubing 4x6mm
• E261MMT11731 - Infusion Set: 2024-12-17 Pump Tubing 4x6mm
• E261UDA462151 - Atmos: 2024-10-18 Pump Tubing 4x6mm
• E261UDA582451 - Atmos: 2024-09-11 Pump Tubing 5x8mm
• E261UDAELN1 - Atmos: 2024-09-11 Transparent extension line 1500mm
• E261UDA362051 - Atmos: 2024-09-10 Pump Tubing 3,2 x 6,4