FDA UDI
In Commercial Distribution
🇺🇸 United States
DOPPLEX
DI: 05051968036544
·
Model: DIPP10
·
HUNTLEIGH HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DOPPLEX
- Primary DI
- 05051968036544
- Version / Model
- DIPP10
- Catalog Number
- DIPP10
- Company Name
- HUNTLEIGH HEALTHCARE LIMITED
- Labeler DUNS
- 217207083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-05
- Public Version
- 1
- Public Version Date
- 2021-05-13
- Public Version Status
- New
- Public Device Record Key
- ac925373-bf81-4662-9a00-31f7f17cbb69
Device Description
DIOP8 PROBE PACK
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61226 | Invasive vascular ultrasound system probe | A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051968036544 | GS1 |
Customer Contacts
- Phone
- +4402920485885
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201425 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 860 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 860 – 1060 millibar
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handling Environment Humidity: between 10 and 90 Percent (%) (Non-condensing) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Environment Humidity: 90% Maximum Relative Humidity