Smart Bulb

Basic Information

• Brand Name: Smart Bulb
• Primary DI: 06009900408330
• Version / Model: 1
• Company Name: WISMED PL SP Z O O
• Labeler DUNS: 850665825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-17
• Public Version: 1
• Public Version Date: 2025-03-25
• Public Version Status: New
• Public Device Record Key: 79817b6c-aa80-4fd5-9483-35fa54897b9a

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06009900408330	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: – 104 Degrees Fahrenheit