Zeni Medical

GUDID 00324357010452

Focus Health Group, Inc.

Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 00324357010452
• NIH Device Record Key: c363a6f8-664c-403c-bf0d-f3b499cfac8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeni Medical
• Version Model Number: 10045-AG
• Company DUNS: 826939949
• Company Name: Focus Health Group, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00324357010452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141619

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Zeni Medical]

• 00324357090447: 90044-AG
• 00324357090225: 90022-AG
• 00324357900449: 90044
• 00324357900227: 90022
• 00324357800695: 80069
• 00324357800459: 80045
• 00324357700476: 70047
• 00324357606600: 600660
• 00324357600882: 60088
• 00324357600660: 60066
• 00324357600455: 60045
• 00324357600226: 60022
• 00324357500663: 50066
• 00324357500441: 50044
• 00324357500229: 50022
• 00324357404107: 400410
• 00324357400666: 40066
• 00324357400444: 40044
• 00324357400222: 40022
• 00324357300997: 30099-S
• 00324357300775: 30077-S
• 00324357300669: 30066
• 00324357300447: 30044
• 00324357300331: 30033
• 00324357300225: 30022
• 00324357300003: 30000-H
• 00324357200662: 20066
• 00324357200440: 20044
• 00324357200228: 20022
• 00324357100887: 10088
• 00324357100665: 10066
• 00324357100450: 10045
• 00324357100221: 10022
• 00324357090010: 900-1g
• 00324357060884: 60088-AG
• 00324357060662: 600660-AG
• 00324357060457: 60045-AG
• 00324357060228: 60022-AG
• 00324357060129: 60012-AG
• 00324357030665: 30066-AG
• 00324357030443: 30044-AG
• 00324357020444: 20044-AG
• 00324357010889: 10088-AG
• 00324357010667: 10066-AG
• 00324357010452: 10045-AG
• 00324357010223: 10022-AG