Smart Bulb

GUDID 06009900408330

Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Smart Bulb is designed for controlled irrigation through an endoscope or accessory during urological procedures.

WISMED PL SP Z O O

Surgical irrigation tubing set, single-use

• Primary Device ID: 06009900408330
• NIH Device Record Key: 79817b6c-aa80-4fd5-9483-35fa54897b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Bulb
• Version Model Number: 1
• Company DUNS: 850665825
• Company Name: WISMED PL SP Z O O
• 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: true
• 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

Customer Support Contacts

• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com
• Phone: +1 (513) 604-3430
• Email: info@acemedicalco.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009900408330 [Primary]

FDA Product Code

• FFY: Adaptor, Bulbs, Miscellaneous, For Endoscope

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: 2025-03-25
• Device Publish Date: 2025-03-17

Devices Manufactured by WISMED PL SP Z O O

• 05906168942228 - Dual Action Pump Hand: 2025-04-04 The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract
• 05906168942211 - Dual Action Pump Foot: 2025-03-25 The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract
• 05906168942235 - Sealing Connector Y piece: 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro
• 05906168942242 - Sealing Connector I Piece: 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro
• 05906168942259 - Sealing Connector T piece: 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro
• 16009900408313 - Peditrol: 2025-03-25 Peditrol is a foot-operated irrigation system that is used during Ureterorenoscopy to facilitate irrigation and manipulation of
• 06009900408330 - Smart Bulb: 2025-03-25Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Smart Bulb is designed for controlled irrigation through an endoscope or accessory during urological procedures.
• 06009900408330 - Smart Bulb: 2025-03-25 Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and help
• 06009900408439 - Mini Pillow: 2025-03-25 Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigat