SMALL ADULT 3 IN 1 MASK R-8155

GUDID 50628725098376

SMALL ADULT 3 IN 1 MASK

Canadian Hospital Specialties Limited

Rebreathing oxygen face mask

• Primary Device ID: 50628725098376
• NIH Device Record Key: 8d588c42-1c20-4602-a641-f23f7f6db728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMALL ADULT 3 IN 1 MASK
• Version Model Number: R-8155
• Catalog Number: R-8155
• Company DUNS: 240992693
• Company Name: Canadian Hospital Specialties Limited
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com
• Phone: 9058259300
• Email: Regulatory.affairs@chsltd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628725098371 [Primary]
GS1	50628725098376 [Package]; Contains: 00628725098371; Package: Corrugate Case [50 Units]; In Commercial Distribution

FDA Product Code

• BYG: Mask, Oxygen

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: 2024-04-12
• Device Publish Date: 2024-04-04

Devices Manufactured by Canadian Hospital Specialties Limited

• 00628725095066 - MISI-Medical Imaging Solutions International: 2025-08-25 CT Angiographic Syringe 1-200ml Syringe, 1-Large Spike, 1-Fill Straw, 1-60" Coiled tubing
• 50628725095153 - MISI-Medical Imaging Solutions International: 2025-08-25 MR Angiographic Syringe 2-100ml syringes, 1-Large Spike, 1-Small Spike, 1-96" Y Coiled Tubing with Dual Check Valves
• 50628725095207 - MISI-Medical Imaging Solutions International: 2025-08-25 MR Angiographic Syringe 2- 60ml Syringes, 1-Large Spike, 1-Small Spike, 1-Fill Straw, 1-96" Y Coiled Tubing with Dual Check Valv
• 50628725095092 - MISI-Medical Imaging Solutions International: 2025-08-15 MR Angiographic Syringe. 1-65ml Syringe , 1-115ml Syringe, 1-Large Spike, 1- Small Spike, 1-96" T Coiled Tubing with Check Valv
• 50628725095115 - MISI-Medical Imaging Solutions International: 2025-08-15 CT Angiographic Syringe 1-200ml Syringe. 1-Fill Straw, 1-Large Spike. 1-60" Coiled Tubing. 1-Drip Tube with plug
• 50628725095122 - MISI-Medical Imaging Solutions International: 2025-08-15 CT Angiographic Syringe 2-200ml Syringes. 1-Drip Tube with plug. 2-Fill Straws. 1- Large spike. 1-60" Y Coiled Tubing with Dual
• 50628725095139 - MISI-Medical Imaging Solutions International: 2025-08-15 CT ANGIOGRAPHIC SYRINGE 1-200ml syringe. 1-Large Spike. 1-Fill Straw. 1-60" Coiled Tubing. 1-Drip Tube with Plug
• 00628725095226 - MISI-Medical Imaging Solutions International: 2025-08-15 CT Angiographic Syringe 2-200ml Syringes, 2-Fill Straws, 1-Large Spike, 1-Small Spike, 1-Drip tubing with plug, -1-60" T Coiled