| Primary Device ID | 05704916001612 | 
| NIH Device Record Key | 7f323c34-a384-4689-b263-47ae2ba3053f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Wireless Remote Control | 
| Version Model Number | UA2370 | 
| Company DUNS | 310093901 | 
| Company Name | Bk Medical ApS | 
| 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 | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| 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 | 
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | |
| Phone | +4544528100 | 
| info@bkmedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05704916001612 [Primary] | 
| ITX | Transducer, Ultrasonic, Diagnostic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-05-15 | 
| Device Publish Date | 2025-05-07 | 
| 05704916001612 | Wireless Remote Control for bkActiv | 
| 05704916000318 | Wireless Remote Control for bk3000 and bk5000 |