babyLance

GUDID 10814247020182

Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick

CLINICAL INNOVATIONS, LLC

Manual blood lancing device, single-use

• Primary Device ID: 10814247020182
• NIH Device Record Key: 280016cc-d4ab-4f05-aea1-48bd5058822c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: babyLance
• Version Model Number: BLN
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020185 [Primary]
GS1	10814247020182 [Package]; Contains: 00814247020185; Package: [50 Units]; In Commercial Distribution
GS1	20814247020189 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223900

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: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [babyLance]

• 10814247020182: Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick
• 10814247020168: Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick
• 10814247020120: Preemie (Pink/White) 0.85 mm depth, Safety Heelstick