| Primary Device ID | 50628725099809 |
| NIH Device Record Key | dcc3ac44-8a5c-45e9-85a8-7c2ae469e220 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric Three-In-One Mask |
| Version Model Number | R-2755S |
| Catalog Number | R-2755S |
| 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 | 00628725099804 [Primary] |
| GS1 | 50628725099809 [Package] Contains: 00628725099804 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 | 2023-07-10 |
| Device Publish Date | 2023-06-30 |
| 50628725096983 - Tavish | 2023-07-14 MASK PEDIATRIC TAVISH OXYGEN 7' SAFLO TUBING |
| 50628725097058 - Adult Nasal Cannula-Vinyl | 2023-07-14 ADULT, CURVED, FLARED VINYL CANNULA W/7' SAFLO OXYGEN TUBING |
| 50628725097263 - 19mm Magenta Tubing Connector | 2023-07-14 SCAVENGER TUBING CONNECTOR (19MM) MAGENTA 50/CS |
| 50628725097010 - Pediatric Aerosol Mask | 2023-07-10 MASK PEDIATRIC AEROSOL FACE |
| 50628725097027 - Jemsdal | 2023-07-10 MASK SMALL ADULT JEMSDAL W/ 7' SAFLO OXYGEN TUBING ETCO2 CONNECTOR |
| 50628725098284 - Tavish | 2023-07-10 MASK ADULT TAVISH OXYGEN 7' SAFLO TUBING |
| 50628725099489 - Adult Oxygen Mask | 2023-07-10 MASK ADULT MEDIUM CONCENTRATION OXYGEN NO TUBING |
| 50628725099793 - Pediatric High Concentration Oxygen Mask | 2023-07-10 MASK PEDIATRIC HIGH CONCENTRATION 7' SAFLO TUBE |