FDA UDI
In Commercial Distribution
🇺🇸 United States
USB A to C Cable
DI: 00853818007491
·
Model: PB-209
·
PRECISION BIOMETRICS INC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- USB A to C Cable
- Primary DI
- 00853818007491
- Version / Model
- PB-209
- Catalog Number
- PB-209
- Company Name
- PRECISION BIOMETRICS INC
- Labeler DUNS
- 362997926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-03
- Public Version
- 1
- Public Version Date
- 2024-09-11
- Public Version Status
- New
- Public Device Record Key
- d277fb9a-a9ba-446b-8b67-d97bf7e32696
Device Description
PB-209, USB A to C cable
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
- No
- 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 |
|---|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | Obstetrics/Gynecology | 884.2980 | 1 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
| KQX | Goniometer, Ac-Powered | Orthopedic | 888.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853818007491 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123399 | 000 |