FDA UDI
In Commercial Distribution
🇺🇸 United States
SYSTEM EBIKE COMFORT US & BP
DI: 04059358000169
·
Model: 2017911-108
·
ergoline GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SYSTEM EBIKE COMFORT US & BP
- Primary DI
- 04059358000169
- Version / Model
- 2017911-108
- Company Name
- ergoline GmbH
- Labeler DUNS
- 314403192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-05-11
- Public Version Status
- Update
- Public Device Record Key
- 671980b5-9e2e-41e0-b8b2-832b95a22ead
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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10383 | Bicycle ergometer | A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training, or rehabiltation and measures this related muscle activity at defined workloads. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059358000169 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 85 | Kilogram | |
| Height | 145 | Centimeter | |
| Width | 60 | Centimeter | |
| Length | 108 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius