| Primary Device ID | 10859020006373 |
| NIH Device Record Key | b5d4e221-c64c-4cb4-a61e-68324ea9f8dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FDK |
| Version Model Number | FT-C15B |
| Catalog Number | FT-C15B |
| Company DUNS | 118811334 |
| Company Name | Fudakang Industrial Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859020006376 [Primary] |
| GS1 | 10859020006373 [Package] Contains: 00859020006376 Package: Inner Pack [4 Units] In Commercial Distribution |
| GS1 | 30859020006360 [Package] Contains: 00859020006376 Package: Case [24 Units] In Commercial Distribution |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-08 |
| Device Publish Date | 2023-12-31 |
| 00859020006369 | FDK ARM CUFF BP MONITOR |
| 10859020006373 | FDK ARM CUFF BP MONITOR |