Infusion Set

GUDID 38032248487186

Pump Tubing 4x6mm

DELTA MED SPA

Urological irrigation set

• Primary Device ID: 38032248487186
• NIH Device Record Key: 0b7d751c-666a-43bf-ba79-412484990f52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infusion Set
• Version Model Number: MMT1173
• Company DUNS: 444776777
• Company Name: DELTA MED SPA
• 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

• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• 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
• 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
GS1	08032248487185 [Primary]
GS1	38032248487186 [Package]; Contains: 08032248487185; Package: shelf box [25 Units]; In Commercial Distribution
GS1	58032248487180 [Package]; Package: shipping box [2 Units]; In Commercial Distribution
HIBCC	E261MMT11730 [Previous]

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: 2025-09-10
• Device Publish Date: 2025-09-02

Devices Manufactured by DELTA MED SPA

• 38032248487124 - Atmos: 2025-09-10 Pump Tubing 4x6 mm
• 08032248487130 - Atmos: 2025-09-10 Pump Tubing 3,2 x 6,4
• 38032248487148 - Atmos: 2025-09-10 Pump Tubing 5x8mm
• 38032248487186 - Infusion Set: 2025-09-10Pump Tubing 4x6mm
• 38032248487186 - Infusion Set: 2025-09-10 Pump Tubing 4x6mm
• 38032248490131 - Atmos: 2025-09-10 Transparent Extension Line 1500mm
• 38032248471031 - Securmeter Foley Manometer: 2025-05-27 Inta-abdominal pressure measuring system
• 38032248007124 - SOL CARE T: 2021-04-07 I.V. Catheter with protector
• 38032248007131 - SOL CARE T: 2021-04-07 I.V. Catheter with protector