FDA UDI
In Commercial Distribution
🇺🇸 United States
Clarius Ultrasound Scanner
DI: 07540205000878
·
Model: Clarius Charger Hub
·
Clarius Mobile Health Corp
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clarius Ultrasound Scanner
- Primary DI
- 07540205000878
- Version / Model
- Clarius Charger Hub
- Catalog Number
- 99-03-00019; 50-02-00039
- Company Name
- Clarius Mobile Health Corp
- Labeler DUNS
- 202522751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-19
- Public Version
- 2
- Public Version Date
- 2020-02-06
- Public Version Status
- Update
- Public Device Record Key
- 9981f496-cbd6-4457-b49e-e9295326c600
Device Description
Multi-port lithium ion battery charger
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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17115 | Noninvasive device battery charger | An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07540205000847 | GS1 | ||||
| Primary | 07540205000878 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180799 | 000 |