Disposable Bulb & Bladder

Basic Information

• Brand Name: Disposable Bulb & Bladder
• Primary DI: 10848956004867
• Version / Model: D30200-210S
• Catalog Number: D30200-210S
• Company Name: HEALTHMARK INDUSTRIES CO., INC.
• Labeler DUNS: 057680480
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 3
• Public Version Date: 2023-01-12
• Public Version Status: Update
• Public Device Record Key: 0af93a33-4600-4a8d-8d61-58826606ab26

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35800	Endoscope inflation bulb	A device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00848956004860	GS1
Primary	10848956004867	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius