Gentlehe

GUDID 26931918164783

One-care_for Micro-preemie_Sterile_500EA/CS

GRI Medical & Electronic Technology Co., Ltd.

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 26931918164783
• NIH Device Record Key: 1dfcd9d7-9870-4f92-8b9a-fb2a9d0f2248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentlehe
• Version Model Number: 1411
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic Technology 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	16931918164786 [Primary]
GS1	26931918164783 [Package]; Contains: 16931918164786; Package: [50 Units]; In Commercial Distribution
GS1	36931918164780 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172712

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Gentlehe]

• 26931918196531: One-care_for toddler_Sterile_500EA/CS
• 26931918164783: One-care_for Micro-preemie_Sterile_500EA/CS