| Primary Device ID | 00860010159415 |
| NIH Device Record Key | 4b0843d9-7636-463c-ba81-9f1c2e3de9de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ChestPal |
| Version Model Number | LUS110 |
| Company DUNS | 228890412 |
| Company Name | CHESTPAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860010159408 [Primary] |
| GS1 | 00860010159415 [Package] Contains: 00860010159408 Package: Box [1 Units] In Commercial Distribution |
| OCR | Lung Sound Monitor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHESTPAL 79386011 not registered Live/Pending |
ChestPal Ltd 2023-10-11 |