FDA UDI
In Commercial Distribution
🇺🇸 United States
DigiDop
DI: 00852785008043
·
Model: DD-300-D5
·
NEWMAN MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DigiDop
- Primary DI
- 00852785008043
- Version / Model
- DD-300-D5
- Catalog Number
- DD-300-D5
- Company Name
- NEWMAN MEDICAL LLC
- Labeler DUNS
- 078686903
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-08
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- cbbf3de4-c9cf-4a5d-b419-c136bbb9e2dc
Device Description
DigiDop 300, non-display, 5MHZ VASCULAR
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
- 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 |
|---|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | Radiology | 892.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44311 | Noninvasive vascular ultrasound system | An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852785008043 | GS1 |
Customer Contacts
- Phone
- 303-974-7689
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090465 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity