FDA UDI
In Commercial Distribution
🇺🇸 United States
Lode B.V.
DI: 08717524640101
·
Model: 938905
·
Lode B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lode B.V.
- Primary DI
- 08717524640101
- Version / Model
- 938905
- Company Name
- Lode B.V.
- Labeler DUNS
- 407774181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-10
- Public Version
- 4
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- 33c2724c-c403-4de7-abf7-a56bd83deb1d
Device Description
938905 Valiant 2 cpet XL
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| IOL | TREADMILL, POWERED | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36679 | Cardiopulmonary stress exercise treadmill | An electrically-powered device designed to be used as a component of a stress test system that permits the evaluation of a patient's physiologic response to physical stress (e.g., workload testing of the cardiac and/or pulmonary disorders/function). It is designed for walking, jogging, or running on a moving belt that facilitates physical exercise while the patient remains on the spot (i.e., treadmill). It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) that rotates at varying speeds and elevation, electric motors, and controls. It will typically incorporate front and side-mounted rails to allow the user to steady themselves. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717524640101 | GS1 |