GeniFirst

Basic Information

• Brand Name: GeniFirst
• Primary DI: 00877972001904
• Version / Model: 130-150-001
• Company Name: GENICON, INC.
• Labeler DUNS: 079805400
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-05
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 88c371f8-1db8-473f-941f-0eebfee9ea00
• Distribution End Date: 2020-05-29

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00877972001904	GS1