Diabetics

GUDID 10848530107557

Sunset Pressure Activated Lancet 21G, 2.0mm - 10/PK

SUNSET HEALTHCARE SOLUTIONS, INC.

Blood lancet, single-use

• Primary Device ID: 10848530107557
• NIH Device Record Key: 69d11d8a-4b74-49ab-bcc1-40a8724da703
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diabetics
• Version Model Number: DIALAN001
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, 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

Customer Support Contacts

• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530107550 [Primary]
GS1	10848530107557 [Package]; Contains: 00848530107550; Package: [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222376

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-29
• Device Publish Date: 2025-12-19

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 10848530107557 - Diabetics: 2025-12-29Sunset Pressure Activated Lancet 21G, 2.0mm - 10/PK
• 10848530107557 - Diabetics: 2025-12-29 Sunset Pressure Activated Lancet 21G, 2.0mm - 10/PK
• 00848530107949 - CPAP Filter: 2025-12-25 Private Labeled"Respironics DreamStation Reusable Filter - 1/PK
• 00848530107956 - CPAP Filter: 2025-12-25 Private Labeled" Respironics Dream Station 2 Reusable Filter - 1/PK
• 00848530107963 - CPAP Filter: 2025-12-25 Private Labeled"Resmed S9 & S10 CPAP Filter - 50/PK
• 00848530107970 - CPAP Filter: 2025-12-25 Private Labeled"Resmed AirMini CPAP Filter - 2/PK
• 00848530107987 - CPAP Filter: 2025-12-25 Private Labeled"Resmed AirMini CPAP Filter - 12/PK
• 00848530107994 - CPAP Filter: 2025-12-25 Private Labeled"Resmed Airsense 11 CPAP Filter - 50/PK
• 10848530108103 - Filter - Vent: 2025-12-25 Sunset Particle Filter for Respironics Trilogy Ventilator – 10/PK