FDA UDI
In Commercial Distribution
🇺🇸 United States
APT PERFORMER
DI: 00092237625712
·
Model: 5100D040
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- APT PERFORMER
- Primary DI
- 00092237625712
- Version / Model
- 5100D040
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-07
- Public Version
- 1
- Public Version Date
- 2024-03-15
- Public Version Status
- New
- Public Device Record Key
- 411c6264-932a-4e96-bfc7-2395334c1e99
Device Description
APT EMERGENCY STOP MODULE REPAIR PART
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
- 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 |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00092237625712 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]