FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter
DI: 00866646000305
·
Model: 490-00183-02, 490-00189-02
·
BUTTERFLY NETWORK, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter
- Primary DI
- 00866646000305
- Version / Model
- 490-00183-02, 490-00189-02
- Company Name
- BUTTERFLY NETWORK, INC.
- Labeler DUNS
- 064617010
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 2
- Public Version Date
- 2020-12-22
- Public Version Status
- Update
- Public Device Record Key
- 04062d4f-97b4-4491-b2c8-0ab9398fd33e
- Distribution End Date
- 2020-12-21
Device Description
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, imaging, pulsed doppler, ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 00866646000305 | GS1 |
Customer Contacts
- Phone
- +1(855)296-6188
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163510 | 000 |