| Primary Device ID | 50628725095542 |
| NIH Device Record Key | 7cfc922c-211b-4be6-9ff2-59cbb93867e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Face mask - Pediatric |
| Version Model Number | R-2755SM |
| Catalog Number | R-2755SM |
| 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 | |
| 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 | 00628725095547 [Primary] |
| GS1 | 50628725095542 [Package] Contains: 00628725095547 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 | 2024-05-24 |
| Device Publish Date | 2024-05-16 |
| 50628725095078 - MISI-Medical Imaging Solutions International | 2025-09-19 MR Angiographic Syringe 2 - 65 ml Syringes, 1 - Large Spike, 1 - Small Spike, 1 - 96" T Coiled Tubing with Check Valve |
| 50628725095085 - MISI-Medical Imaging Solutions International | 2025-09-19 Angiographic Syringe 1-150ml Syringe, 1-Fill Straw |
| 50628725095108 - MISI-Medical Imaging Solutions International | 2025-09-19 CT Angiographic Syringe 1 - 200 ml Syringe, 1 - Fill Straw, 1 - Large Spike, 1 - 60" Coiled Tubing, 1 - Drip Tubing with Plug |
| 50628725095160 - MISI-Medical Imaging Solutions International | 2025-09-19 CT Angiographic Syringe 1 - 150 ml Syringe, 1 - Fill Straw |
| 50628725095177 - MISI-Medical Imaging Solutions International | 2025-09-19 CT Angiographic Syringe 2 - 200 ml Syringes, 2 - Fill Straws, 1- Drip Tubing with Plug, 1 - Large Spike, 1 - 60" Y Coiled Tubing |
| 50628725095184 - MISI-Medical Imaging Solutions International | 2025-09-19 CT Angiographic Syringe 1 - 200ml Syringe, 1 - 60" Coiled Tubing, 1 - Large Spike, 1 - Drip Tubing with Plug, 1 - Fill Straw |
| 50628725095191 - MISI-Medical Imaging Solutions International | 2025-09-19 MR Angiographic Syringe 1 - 60 ml Syringe, 1 - Large Spike, 1 - Fill Straw, 1 - 96" Y Coiled Tubing with Dual Check Valves |
| 50628725095214 - MISI-Medical Imaging Solutions International | 2025-09-19 CT Angiographic Syringe 1 - 200 ml Syringe, 1 - Drip Tubing with Plug, 1 - Large Spike, 1 - Fill Straw, 1 - 60" Y Coiled Tubing |