| Primary Device ID | 50628725096976 | 
| NIH Device Record Key | 31ce727e-023f-4e63-afd4-5b8cb3e27a24 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pediatric Non-Rebreathing Oxygen Mask | 
| Version Model Number | R-2950SM | 
| 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 | 
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | |
| Phone | 9058259300 | 
| Regulatory.affairs@chsltd.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00628725096971 [Primary] | 
| GS1 | 50628725096976 [Package] Contains: 00628725096971 Package: Corrugate Case [50 Units] In Commercial Distribution | 
| KGB | Mask, Oxygen, Non-Rebreathing | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-04-30 | 
| Device Publish Date | 2024-04-22 | 
| 50628725096938 | Mask Pediatric Non-Rebreathing, Two Valves, 7ft. Saflo Tube - multi-fit on one end | 
| 50628725096976 | PEDIATRIC NON-REBREATHING OXYGEN MASK ONE SIDE VALVE, 7' SAFLO TUBE, W/MULTI FIT CONNECTOR |