FDA UDI
In Commercial Distribution
🇺🇸 United States
BladderScan®
DI: 00879123008015
·
Model: Prime Plus™
·
VERATHON INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BladderScan®
- Primary DI
- 00879123008015
- Version / Model
- Prime Plus™
- Catalog Number
- E570-0395
- Company Name
- VERATHON INC
- Labeler DUNS
- 130598584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-29
- Public Version
- 1
- Public Version Date
- 2021-11-08
- Public Version Status
- New
- Public Device Record Key
- 99a468ca-2286-4e45-9a21-b8727ccc9e05
Device Description
BladderScan® Prime Plus™ Probe, Probe Exchange
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45546 | Bladder ultrasound imaging transducer | An ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also referred to as a bladder, or urethra probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10879123008012 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 00879123008015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153101 | 000 |