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

• 00848530108618 - CPAP Filter: 2026-03-27 Replacement Reusable Foam Filter 2/pkg ResPlus Oxygo AutoPAP Machine
• 00848530108632 - CPAP Tubing: 2026-03-27 Premium CPAP Tube, Rubber Cuffs, Gray, 8 ft.
• 00848530108472 - Oxygen, Bacteria & HEPA Filter: 2026-03-25 Invarecare 50PSI Foam Inlet Filter - 10/PK
• 00848530108489 - CPAP Filter: 2026-03-25 Filter, USA, AirSense 11, Standard 12 per pack
• 10848530108646 - Repair Parts: 2026-03-25 Heat Exchanger Assembly for Perfecto2 and Perfecto2V
• 00848530108656 - Repair Parts: 2026-03-25 Invacare Platinum 10L Flow Meter
• 10848530108660 - Repair Parts: 2026-03-25 Sieve Everflo Muffler Insulation
• 10848530108677 - Repair Parts: 2026-03-25 P2 Compressor Rebuild Kit with Top End and Bottom Flapper Assembly + Cup and Sleeve