FDA UDI
In Commercial Distribution
🇺🇸 United States
Clarius Ultrasound Scanner
DI: 07540205001370
·
Model: Clarius Fan HD3
·
Clarius Mobile Health Corp
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Clarius Ultrasound Scanner
- Primary DI
- 07540205001370
- Version / Model
- Clarius Fan HD3
- Catalog Number
- 99-03-00024, 50-02-00077
- Company Name
- Clarius Mobile Health Corp
- Labeler DUNS
- 202522751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-29
- Public Version
- 1
- Public Version Date
- 2022-10-07
- Public Version Status
- New
- Public Device Record Key
- 770d6fc8-e44d-49d4-b211-d85f847ff00b
Device Description
Accessory - Fan for Clarius Ultrasound Scanner
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36824 | Electric cooling fan | A mains electricity (AC-powered) device intended to be used to cool a patient by blowing a stream of ambient air toward or over the patient. As the device is used near patients, and in the vicinity of and in conjunction with other advanced medical devices, it should meet the same hospital grade electrical safety requirements as the other electrical devices. It can be mounted on a table stand or a wall mount. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540205001370 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213436 | 000 |