Firstar

GUDID B448FS1041

FS-104 CPR Mask for professional mouth to mouth rescusitation

Firstar Healthcare Company Limited (Guangzhou)

Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: B448FS1041
• NIH Device Record Key: 068f715f-f542-45fe-a2a5-79c924e0e9ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Firstar
• 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: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +862039026292
• Email: eddie@china-firstar.com
• Phone: +862039026292
• Email: eddie@china-firstar.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B448FS1041 [Primary]
HIBCC	B448FS1042 [Package]; Package: case [50 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-06

On-Brand Devices [Firstar]

• B448FS1041: FS-104 CPR Mask for professional mouth to mouth rescusitation
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• B44848525: 4852 Boby fluid Clean Up kit for clean and protective
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• B44891018S741: First aid and dressing
• B44849660: 4966