Rocoto
- Primary DI
- 00860015454737
- Brand
- Rocoto
- Company
- Rocoto Inc.
- Model
- MD11 Rx device - MDWL1_B1J1RX
- Published
- 2026-02-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| OUG | Medical Device Data System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OUG | Medical Device Data System | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860015454737 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Medical image management system | A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)]. |
Regulatory Flags
- DUNS number
- 960475866
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860015454706 | Rocoto | MD62 Tx Device - MDWL2_B1J1TX | | 2026-02-26 |
| 00860015454713 | Rocoto | MD62 Rx Device - MDWL2_B1J1RX | | 2026-02-26 |
| 00860015454720 | Rocoto | MD11 Tx device - MDWL1_C1N1TX | | 2026-02-26 |
| 00860015454744 | Rocoto | SL11 device - Wireless Camera - MDMP1_SL11_1STE12 | | 2026-02-26 |
| 00860015454751 | Rocoto | SL11 device Sterilizable Cover - AMN_ASM_1030 | | 2026-02-26 |
| 00860015454768 | Rocoto | MD52 Tx - MDWL2_B1P1TX | | 2026-02-26 |
| 00860015454775 | Rocoto | MD52 Rx - MDWL2_B3P1RX | | 2026-02-26 |
| 00860015454782 | Rocoto | HM11 Device - MDWL1_HM11 | | 2026-02-26 |
| 00860014100604 | Amimon | MD62 Tx device - MDWL2_B1J1TX | MDWL2_B1J1TX | 2025-06-24 |
| 00860014100611 | Amimon | MD62 Rx device - MDWL2_B1J1RX | MDWL2_B1J1RX | 2025-06-24 |
| 00860014100628 | Amimon | MD11 Tx device - MDWL1_C1N1TX | MDWL1_C1N1TX | 2025-06-24 |
| 00860014100635 | Amimon | MD11 Rx device - MDWL1_B1N1RX | MDWL1_B1N1RX | 2025-06-24 |
| 00860014100642 | Amimon | SL11 device - Wireless Camera - MDMP1_SL11_1STE12 | MDMP1_SL11_1STE12 | 2025-06-24 |
| 00860014100659 | Amimon | SL11 Sterilizable Cover - AMN_ASM_1030 | AMN_ASM_1030 | 2025-06-24 |
| 00860014100666 | Amimon | MD52 Tx device - MDWL2_B1P1TX | MDWL2_B1P1TX | 2025-06-24 |
| 00860014100673 | Amimon | MD52 Rx device - MDWL2_B3P1RX | MDWL2_B3P1RX | 2025-06-24 |
| 00860014100680 | Amimon | HM11 Device - MDWL1_HM11 | MDWL1_HM11 | 2025-06-24 |
Other Devices Sharing Product Codes