FDA UDI
In Commercial Distribution
🇺🇸 United States
Kosmos Bridge - Refurbished
DI: 09353278000458
·
Model: R006030
·
ECHONOUS, INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kosmos Bridge - Refurbished
- Primary DI
- 09353278000458
- Version / Model
- R006030
- Company Name
- ECHONOUS, INC.
- Labeler DUNS
- 080481089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-11
- Public Version
- 1
- Public Version Date
- 2020-12-21
- Public Version Status
- New
- Public Device Record Key
- 6a9e2e5a-86b0-4863-a177-25c1a4725c50
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
| DQD | Stethoscope, Electronic | Cardiovascular | 870.1875 | 2 |
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64846 | Ultrasound/electrocardiograph/stethoscope unit | An electrically-powered modular device intended for general medical examination using ultrasound, electrocardiograph (ECG) and auscultation modalities, with a user interface that enables synchronized data display and recording. It consists of a multi-purpose transducer designed for transmitting/receiving ultrasound and sensing sound signals, to which an ECG lead assembly can be attached, and a connected image display monitor (e.g., tablet) with dedicated software; in addition to the integrated electronic stethoscope, it may also allow connection of a stethoscope headset for the user to directly hear sounds. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09353278000458 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193518 | 000 |