| Primary Device ID | 20889483047917 |
| NIH Device Record Key | f0acbbee-a3ac-4585-a450-77618da779c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SunMed LLC |
| Version Model Number | 9-0210-21I |
| Catalog Number | 9-0210-21I |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 10889483047910 [Primary] |
| GS1 | 20889483047917 [Package] Contains: 10889483047910 Package: BX [25 Units] In Commercial Distribution |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-19 |
| Device Publish Date | 2024-11-11 |
| 30889483553613 | Pediatric, Noon-intubated, 7ft Oral/Nasal with Oxygen Tubing |
| 30889483565630 | AirFlow Adult Resuscitator with B/V Filter, Bag Reservoir, Mask, Attached PEEP Valve and 14' Tub |
| 20889483047917 | IGuard Pediatric Eye Protector E-Series/Non-Sterile |