DOUBLE INSUFFLATION BULB

Basic Information

• Brand Name: DOUBLE INSUFFLATION BULB
• Primary DI: 04053755125999
• Version / Model: 000
• Catalog Number: E-000.18.105
• Company Name: Heine Optotechnik GmbH & Co. KG
• Labeler DUNS: 315274563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: a6401c3a-7187-4739-956e-fd011f18814c

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCM	Endoscope, Rigid	Gastroenterology, Urology	876.1500	2

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
Primary	04053755125999	GS1

Customer Contacts

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