FDA UDI
In Commercial Distribution
🇺🇸 United States
Drive
DI: 00822383286365
·
Model: E-10270SV-2
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Drive
- Primary DI
- 00822383286365
- Version / Model
- E-10270SV-2
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 2
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- b73a9853-acde-4772-98e9-76011751452e
Device Description
Personal CareExercise Peddler Product Description: Enfer Exercise Peddler,SilverVein,2/cs
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
- 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 |
|---|---|---|---|---|
| ION | EXERCISER, NON-MEASURING | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10385 | Bicycle exerciser | An exercise apparatus designed to provide the same physical activity of pedalling a bicycle while remaining stationary, primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period; it may also promote lower-body, stomach, arm, and back muscle strength. The device typically consists of a bicycle-like frame mounted on struts, pedals geared via a chain or belt to a variable resistance, handlebars, with a fixed seat or attachment for a wheelchair. It may include workout program modes to adjust the resistance level, a monitor to display the workout time, distance, speed, calories burned, and heart rate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50822383286360 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00822383286365 | GS1 |