FDA UDI
In Commercial Distribution
🇺🇸 United States
KINVENT
DI: 03770011995448
·
Model: Bubble V2R01
·
KINVENT HELLAS
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KINVENT
- Primary DI
- 03770011995448
- Version / Model
- Bubble V2R01
- Company Name
- KINVENT HELLAS
- Labeler DUNS
- 524664525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-01
- Public Version
- 3
- Public Version Date
- 2021-11-30
- Public Version Status
- Update
- Public Device Record Key
- 69b3719c-5a76-4475-a072-4fb69d3b141e
Device Description
Bubble is a pneumatic sensor allowing you to work your strength with convenient inflatable tools.
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
- Yes
- 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 |
|---|---|---|---|---|
| LBB | Dynamometer, Ac-Powered | Orthopedic | 888.1240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61672 | Back/leg/chest dynamometer, electronic | A portable, hand-held, electrically-powered, digital instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess force generated during a variety of movements (e.g., leg abduction, lifting) and/or force required to be exerted by a clinician to overcome a patient’s resistance (break test techniques). Is typically used to test or control a patient's muscle strength as part of a rehabilitation program. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770011995448 | GS1 | ||||
| Package | 03770011995073 | GS1 | Rehab Box | 1 | In Commercial Distribution | |
| Package | 03770011995080 | GS1 | Physio Sport Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +33467130033
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius