ARKRAY Multi-let 2 Lancing Device

GUDID 00015482660161

A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.

ARKRAY USA, INC.

Manual blood lancing device, reusable

• Primary Device ID: 00015482660161
• NIH Device Record Key: 78a25fa1-870f-4a05-ae47-209a3a964ed3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARKRAY Multi-let 2 Lancing Device
• Version Model Number: 660016
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482660161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221175

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-08
• Device Publish Date: 2018-09-24

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