Plus Medical Chemotherapy Gown

GUDID 16973062321448

Foshan Nanhai Plus Medical Co., Ltd

Surgical gown, single-use

• Primary Device ID: 16973062321448
• NIH Device Record Key: b5e5bba5-0467-42fd-b2ac-142d952d859c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plus Medical Chemotherapy Gown
• Version Model Number: PM8801CG
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973062321441 [Primary]
GS1	16973062321448 [Package]; Contains: 06973062321441; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211036

FDA Product Code

• FYA: Gown, Surgical

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: 2022-05-25
• Device Publish Date: 2022-05-17

On-Brand Devices [Plus Medical Chemotherapy Gown]

• 16973062321479: PM8804CG
• 16973062321462: PM8803CG
• 16973062321455: PM8802CG
• 16973062321448: PM8801CG
• 16973062321639: PM8806CG
• 16973062321622: PM8805CG
• 16973062321615: PM8800CG
• 16973062321608: PM88X0CG