STAT Medical Devices SM-QLL-L02

GUDID 00709334980001

The reusable lancing device is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The lancing device is to be used with single-use lancets.

Stat Medical Devices, Inc.

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• Primary Device ID: 00709334980001
• NIH Device Record Key: da976d7e-5680-4583-ae44-b724e0dfe1ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAT Medical Devices
• Version Model Number: LITE Lancing Device
• Catalog Number: SM-QLL-L02
• Company DUNS: 967687286
• Company Name: Stat Medical Devices, 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: false
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709334980001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222034

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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: 2023-12-06
• Device Publish Date: 2023-11-28

On-Brand Devices [STAT Medical Devices]

• 00709334992004: TRIO Lancing Device
• 00709334980001: The reusable lancing device is intended for the hygienic collection of capillary blood for testi
• 30709334883884: The Disposable Safety Lancet is intended for capillary blood sampling.
• 50709334581210: The sterile, single-use lancets is intended for the hygienic collection of capillary blood for t
• 40709334761882: The Disposable Safety Lancet is intended for capillary blood sampling.