FDA UDI
In Commercial Distribution
🇺🇸 United States
WHALE
DI: 06970528550032
·
Model: P5
·
Beijing East Whale Imaging Technology Co.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WHALE
- Primary DI
- 06970528550032
- Version / Model
- P5
- Company Name
- Beijing East Whale Imaging Technology Co.,Ltd.
- Labeler DUNS
- 529847741
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-04
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6682efe2-c8bd-423a-86ac-e655b6a53408
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 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36208 | Ultrasound mobile medical facility | A vehicle, e.g., a van, trailer, or other kind of mobile enclosure, that is equipped with at least one diagnostic ultrasound system and related instrumentation. It is typically driven or towed between various geographical locations and used as a freestanding ultrasound imaging mobile unit. It will include special mounting and stabilization components for the installed ultrasound systems and other devices, e.g., film processors, telemedicine systems, picture archiving and communication system (PACS), or camera. Power sources and other equipment necessary to ensure adequate functioning of the system(s), are included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970528550032 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160343 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 598 | Millimeter | |
| Length | 524 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal