Zhibo

GUDID 06973244780004

It is applicable to the health protection of the wearer in the ordinary medical environment without the risk of liquid and splashing.

Xiantao Zhibo Nonwoven Products Co.,Ltd

Surgical/medical face mask, single-use

• Primary Device ID: 06973244780004
• NIH Device Record Key: 2a034cab-4345-4722-9163-7178fc600ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zhibo
• Version Model Number: 1
• Company DUNS: 548298805
• Company Name: Xiantao Zhibo Nonwoven Products 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973244780004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182514

FDA Product Code

• FXX: Mask, 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: 2020-09-14
• Device Publish Date: 2020-09-04