| 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 |