| Primary Device ID | 50628725097416 |
| NIH Device Record Key | d3b22db6-d32b-4eb3-a63f-5caef635ace7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric Aerosol Mask |
| Version Model Number | R-2500/50 |
| Catalog Number | R-2500/50 |
| Company DUNS | 243175213 |
| Company Name | Respan Products Inc |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628725097411 [Primary] |
| GS1 | 50628725097416 [Package] Contains: 00628725097411 Package: Corrugate Case [50 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
| 50628725097942 | MASK PEDIATRIC AEROSOL FACE W/ 7' SAFLO OXYGEN TUBING |
| 50628725097416 | MASK PEDIATRIC AEROSOL |
| 50628725097010 | MASK PEDIATRIC AEROSOL FACE |