PNEUMOSTOP®

Basic Information

• Brand Name: PNEUMOSTOP®
• Primary DI: 00850012846017
• Version / Model: 110230
• Catalog Number: 110230
• Company Name: LSI Solutions, Inc.
• Labeler DUNS: 603420183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2022-11-04
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: 046da86e-0bd6-4c40-8d09-555f56833f10

Device Description

PNEUMOSTOP® PLUS DEVICE

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: 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: 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
NWW	Hysteroscope accessories	Obstetrics/Gynecology	884.1690	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64599	Laparoscopic hysterectomy vaginal occluder	A semi-soft device designed to be inserted into the vagina to maintain pneumoperitoneum during removal of the uterus during laparoscopic hysterectomy. It is in the form of a cylinder with ridges and is made of synthetic polymer materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850012846014	GS1	Case	6	In Commercial Distribution
Primary	00850012846017	GS1
Unit of Use	40850012846015	GS1
Previous	00850200006759	GS1

Customer Contacts

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