| Primary Device ID | 50628725098383 |
| NIH Device Record Key | 8e972970-d9cd-4dad-9061-03f8c97f05a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adult Oxygen Mask |
| Version Model Number | R-8200S |
| Catalog Number | R-8200S |
| 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 | 00628725098388 [Primary] |
| GS1 | 50628725098383 [Package] Contains: 00628725098388 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 |
| 50628725098383 | MASK SMALL ADULT OXYGEN MEDIUM CONCENTRATION W/ 7' SAFLO OXYGEN TUBING |
| 50628725099489 | MASK ADULT MEDIUM CONCENTRATION OXYGEN NO TUBING |