STAT Medical Devices RQL-100

GUDID 30709334883884

The Disposable Safety Lancet is intended for capillary blood sampling.

Stat Medical Devices, Inc.

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use

• Primary Device ID: 30709334883884
• NIH Device Record Key: 18b08ebb-e246-4b8e-97cd-a4253a3cb55e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAT Medical Devices
• Version Model Number: Qwik-Lance Safety Lancet
• Catalog Number: RQL-100
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709334883883 [Primary]
GS1	30709334883884 [Package]; Contains: 00709334883883; Package: Shipper [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222408

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: 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.