GRI

GUDID 16931918100067

Gentleheel Devices are made of lower housing, upper housing, spring, blade, spring holder, blade holder, safety lock, button, etc. Materials of all co

GRI Medical & Electronic Technology Co., Ltd.

Manual blood lancing device, single-use

• Primary Device ID: 16931918100067
• NIH Device Record Key: da9aa386-adad-4069-a377-d8a6034e5a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRI
• Version Model Number: GHN10X50
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16931918100067 [Primary]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-29

Devices Manufactured by GRI Medical & Electronic Technology Co., Ltd.

• 06931918118171 - Invenio: 2024-07-25 Biodegradable Banded bag_heatseal_w/rubberband&tape_30inx30in_bulk_N/S_100ea/cs
• 06931918148529 - Beaver Visitec Inter: 2024-07-25 Remote_Cover_Plastic_15x19cm_Non-sterile_100EA/CS
• 06931918154209 - Beaver Visitec Inter: 2024-07-25 Armboard cover w/ tape_SMS_38cmx80cm_Non-sterile_Handi-Bin_4320EA/CS
• 26931918167050 - Invenio: 2024-07-25 Biodegradable Banded bag_heatseal_w/rubberband&tape_30inx30in_Sterile_25ea/cs
• 06931918115217 - HALYARD: 2024-06-19 Lift Sheet_40inx60in_Soft_White_Bulk_Non-Sterile_100ea/cs
• 06931918115439 - HALYARD: 2024-06-19 Drawcord Bag_Clear_38inx38in_1.8mil_N/S_100ea/cs
• 06931918116108 - HALYARD: 2024-06-19 Kick Bucket Bag_Red_23inx24in_1.3mil_N/S_250ea/cs
• 06931918121980 - HALYARD: 2024-06-19 Armboard Cover_13inX30in_1ea Strap_N/S_150ea/cs