PNEUMOSTOP® 110230

GUDID 10850012846014

PNEUMOSTOP® PLUS DEVICE

LSI Solutions, Inc.

Laparoscopic hysterectomy vaginal occluder

• Primary Device ID: 10850012846014
• NIH Device Record Key: 046da86e-0bd6-4c40-8d09-555f56833f10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUMOSTOP®
• Version Model Number: 110230
• Catalog Number: 110230
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012846017 [Primary]
GS1	00850200006759 [Previous]
GS1	10850012846014 [Package]; Contains: 00850012846017; Package: Case [6 Units]; In Commercial Distribution
GS1	40850012846015 [Unit of Use]

FDA Product Code

• NWW: Hysteroscope accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [PNEUMOSTOP®]

• 10850200006756: PNEUMOSTOP® PLUS DEVICE Each sterile pouch contains one single patient use PNEUMOSTOP® PLUS DE
• 10850200006749: PNEUMOSTOP® DEVICE Each sterile pouch contains one single patient use PNEUMOSTOP® DEVICE.
• 10850012846014: PNEUMOSTOP® PLUS DEVICE
• 10850012846007: PNEUMOSTOP® DEVICE