STAT Medical Devices BTM-100

GUDID 50709334581210

The sterile, single-use lancets 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 lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

Stat Medical Devices, Inc.

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• Primary Device ID: 50709334581210
• NIH Device Record Key: ccccf311-cee6-4fd8-8c09-529da04dfde9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAT Medical Devices
• Version Model Number: Comfort Thins Twist-Off Lancet
• Catalog Number: BTM-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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709334581215 [Primary]
GS1	50709334581210 [Package]; Contains: 00709334581215; Package: Shipper [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222034

FDA Product Code

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

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.