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

• 50628725099755 - PEDIATRIC HIGH CONCENTRATION OXYGEN MASK: 2024-11-15 PEDIATRIC HIGH CONCENTRATION OXYGEN MASK
• 50628725098208 - VixOne™ Nebulizer Kit: 2024-08-28 UP-DRAFT BOTTOM CONNECTION NEBULIZER VIXONE WITH 7ft SAFLO
• 00628725097169 - Oxygen Wrench: 2024-07-29 OXYGEN WRENCH
• 50628725097621 - Oxygen Wrench: 2024-07-29 OXYGEN WRENCH WITH SECURITY CHAIN
• 50628725000195 - Med-Rx: 2024-07-25 MICROBORE TUBING (I.D 0.023") W/ PINCH CLAMP, M/F LL.
• 50628725000218 - Med-Rx: 2024-07-25 MINIBORE TUBING (I.D 0.050") W/ SLIDE CLAMP, M/F LL.
• 50628725000232 - Med-Rx: 2024-07-25 MINIBORE TUBING (I.D 0.050") W/ SLIDE CLAMP, M/F L.L.
• 50628725000379 - Med-Rx: 2024-07-25 STANDARD BORE TUBING (I.D 0.095") W/ PINCH CLAMP, M/F LL