GUDID 06973140040028

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Juntech (Jiaxing) Healthcare Materials Co., Ltd.

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use

• Primary Device ID: 06973140040028
• NIH Device Record Key: ed588ba3-8514-4306-abc3-9de73bd8a915
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: JTMK01-A
• Company DUNS: 421275965
• Company Name: Juntech (Jiaxing) Healthcare Materials Co., Ltd.
• Device Count: 50
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com
• Phone: +86 15651939755
• Email: diego.heng@juntai-tech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973140040011 [Primary]
GS1	06973140040028 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203704

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: 2021-08-19
• Device Publish Date: 2021-08-11