Seal Quik

GUDID B448FS1040

FS-104 CPR MASK

Firstar Healthcare Company Limited (Guangzhou)

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: B448FS1040
• NIH Device Record Key: ee35fbe3-7ca1-4c90-92f2-2c3810ebc4c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seal Quik
• Version Model Number: FS-104
• Company DUNS: 529576331
• Company Name: Firstar Healthcare Company Limited (Guangzhou)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B448FS1040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083418

FDA Product Code

• CBP: Valve, Non-Rebreathing

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: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by Firstar Healthcare Company Limited (Guangzhou)

• B448FS1040 - Seal Quik: 2025-12-18FS-104 CPR MASK
• B448FS1040 - Seal Quik: 2025-12-18 FS-104 CPR MASK
• B4484852KITPPE0 - callington: 2025-10-03 Spill kit
• B448A0020030 - MICRO BIRD: 2025-10-03 First Aid Kit
• B448FA050 - Firstar: 2025-10-03 First Aid Kit
• B448SQ12120 - BrightCare: 2025-06-27 SQ1212 First Aid Kit
• B448SQ12130 - BrightCare: 2025-06-27 SQ1213 First Aid Kit
• B448SQ12140 - BrightCare: 2025-06-27 SQ1214 First Aid Kit
• B448SQ12150 - BrightCare: 2025-06-27 SQ1215 First Aid Kit