Peform Health PrecisionFit Full Face CPAP Mask- Large

GUDID 00848530106478

CPAP Mask with cushion and headgear - Large

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00848530106478
• NIH Device Record Key: c3e22b01-971a-492b-b085-8c86a712e334
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peform Health PrecisionFit Full Face CPAP Mask- Large
• Version Model Number: PH0302
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530106478 [Primary]

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2025-07-30
• Device Publish Date: 2025-07-22

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530106454 - Perform Health PrecisionFit Full Face CPAP Mask - Small: 2025-07-30 CPAP mask with cushion and headgear
• 00848530106461 - Peform Health PrecisionFit Full Face CPAP Mask - Mediom: 2025-07-30 CPAP mask with cushion and headgear
• 00848530106478 - Peform Health PrecisionFit Full Face CPAP Mask- Large: 2025-07-30CPAP Mask with cushion and headgear - Large
• 00848530106478 - Peform Health PrecisionFit Full Face CPAP Mask- Large: 2025-07-30 CPAP Mask with cushion and headgear - Large
• 00848530106485 - Perform Health PrecisionFit Full Face Cushion - Small: 2025-07-30 CPAP Cushion - Small
• 00848530106492 - Perform Health PrecisionFit Full Face Cushion - Medium: 2025-07-30 CPAP Cushion - Medium
• 00848530106508 - Perform Health PrecisionFit Full Face Cushion - Large: 2025-07-30 CPAP Cusion - Large
• 10848530106710 - CPAP Carry Bag for ResMed AirSense 11: 2025-07-29 CPAP Carry Bag
• 00848530106447 - Oxygen Kit: 2025-07-25 Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1)