AccuMedx

Basic Information

• Brand Name: AccuMedx
• Primary DI: 00850059707012
• Version / Model: AMVN-150
• Company Name: Accumedx, LLC
• Labeler DUNS: 096236324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-23
• Public Version: 1
• Public Version Date: 2024-01-31
• Public Version Status: New
• Public Device Record Key: ba1c1106-c964-4b56-bf5e-197ffa757886

Device Description

150 mm Length Stainless Steel Veress Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	876.1500	2
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	00850059707012	GS1
Package	00850059707043	GS1	Inner Pack	25	In Commercial Distribution
Package	00850059707050	GS1	Case	20	In Commercial Distribution