Plus Medical Isolation Gown Level 3

GUDID 16973062321301

Foshan Nanhai Plus Medical Co., Ltd

Isolation gown, single-use

• Primary Device ID: 16973062321301
• NIH Device Record Key: 485bd80c-84e3-4218-891f-bb0198021b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plus Medical Isolation Gown Level 3
• Version Model Number: PM4403FG
• Company DUNS: 529796225
• Company Name: Foshan Nanhai Plus Medical Co., Ltd
• 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: true
• Expiration Date: false
• 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	06973062321304 [Primary]
GS1	16973062321301 [Package]; Contains: 06973062321304; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212698

FDA Product Code

• FYC: Gown, Isolation, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-17
• Device Publish Date: 2022-03-09

On-Brand Devices [Plus Medical Isolation Gown Level 3]

• 16973062321356: PM4408FG
• 16973062321349: PM4407FG
• 06973062321335: PM4406FG
• 16973062321325: PM4405FG
• 16973062321318: PM4404FG
• 16973062321301: PM4403FG
• 16973062321295: PM4402FG
• 16973062321288: PM4401FG