FDA UDI
In Commercial Distribution
🇺🇸 United States
E-LINK DG1 Wireless Dongle
DI: 05060481690195
·
Model: DG1
·
BIOMETRICS LIMITED
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- E-LINK DG1 Wireless Dongle
- Primary DI
- 05060481690195
- Version / Model
- DG1
- Company Name
- BIOMETRICS LIMITED
- Labeler DUNS
- 519969810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-09
- Public Version
- 2
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 2135afc7-310a-43e7-a551-41660e3c92c6
Device Description
The wireless Dongle (DG1) enables E-LINK to be used as a complete stand-alone wireless evaluation and exercise system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
| ION | Exerciser, Non-Measuring | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32547 | Medical networking interface unit | An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060481690195 | GS1 |