FDA UDI
In Commercial Distribution
🇺🇸 United States
NovaKit™ 2 Exam Pack
DI: 00850681007283
·
Model: 25-00004
·
Novasignal Corp.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- NovaKit™ 2 Exam Pack
- Primary DI
- 00850681007283
- Version / Model
- 25-00004
- Catalog Number
- NSC-NVK
- Company Name
- Novasignal Corp.
- Labeler DUNS
- 078766464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-19
- Public Version
- 1
- Public Version Date
- 2022-08-29
- Public Version Status
- New
- Public Device Record Key
- 65b98a97-0f8d-4ada-b17c-09096beb78af
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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63568 | Noninvasive vascular ultrasound support kit | A collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850681007351 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00850681007283 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213279 | 000 |