FDA UDI
In Commercial Distribution
🇺🇸 United States
Senti Desktop Flex (Basic Set)
DI: 04260223142987
·
Model: 100470
·
PATH medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Senti Desktop Flex (Basic Set)
- Primary DI
- 04260223142987
- Version / Model
- 100470
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-20
- Public Version
- 5
- Public Version Date
- 2023-08-03
- Public Version Status
- Update
- Public Device Record Key
- 0bf3960f-f47f-43af-8026-95d86c679eee
Device Description
Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 3 AN100114 7. Bone Conductor B81 AN100888 or B71W AN100344 optionally 8. Patient response button AN100171 9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally 10. USB data cable AN100418
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37503 | Tone audiometer | An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260223142987 | GS1 |