FDA UDI
In Commercial Distribution
🇺🇸 United States
Biim Ultrasound L12-4 Linear Array Transducer
DI: 07090045490006
·
Model: P001000
·
Biim Ultrasound AS
Product Codes
3
GMDN Terms
2
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Biim Ultrasound L12-4 Linear Array Transducer
- Primary DI
- 07090045490006
- Version / Model
- P001000
- Catalog Number
- P001000
- Company Name
- Biim Ultrasound AS
- Labeler DUNS
- 671316618
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-26
- Public Version
- 6
- Public Version Date
- 2019-01-17
- Public Version Status
- Update
- Public Device Record Key
- f765f6da-d8fe-49ac-b65a-f967d0b58b4b
Device Description
Biim Ultrasound L12-4 Linear Array Transducer
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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40768 | Extracorporeal ultrasound imaging transducer, hand-held | A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device. | No | Active |
| 60924 | Hand-held ultrasound imaging system, body-surface | A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07090045490006 | GS1 | ||||
| Package | 07090045490082 | GS1 | BX | 1 | In Commercial Distribution | |
| Package | 07090045490167 | GS1 | BX | 1 | In Commercial Distribution | |
| Package | 07090045490280 | GS1 | EA | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173138 | 000 |