| Primary Device ID | 20794503812362 |
| NIH Device Record Key | 88bfec86-b32e-419d-b968-3488223c961e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Up & Up |
| Version Model Number | 81236 |
| Company DUNS | 809994163 |
| Company Name | CIRRUS HEALTHCARE PRODUCTS LLC |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00794503812368 [Primary] |
| GS1 | 20794503812362 [Package] Contains: 00794503812368 Package: Case [24 Units] Discontinued: 2021-03-11 Not in Commercial Distribution |
| EWD | Protector, Hearing (Insert) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-25 |
| Device Publish Date | 2021-03-17 |
| 20794503812362 | Cirrus Healthcare Products, 245-09-4315, Flight Earplugs 2 Pair, Nicholas Petry, Npetry@cirrushe |
| 20794503812348 | Cirrus Healthcare Products, 245-09-0047, Sleep Earplugs 2 Pair, Nicholas Petry, Npetry@cirrushea |