FDA UDI
In Commercial Distribution
🇺🇸 United States
SERVOX digital XL
DI: 04040823006502
·
Model: 37575
·
Servona GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SERVOX digital XL
- Primary DI
- 04040823006502
- Version / Model
- 37575
- Company Name
- Servona GmbH
- Labeler DUNS
- 329895200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-18
- Public Version
- 1
- Public Version Date
- 2021-02-26
- Public Version Status
- New
- Public Device Record Key
- 58f97477-28df-4acb-a8a4-d696f4388b89
Device Description
The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgical removal of the larynx, the opportunity to quickly regain the ability to communicate. The SERVOX® digital XL can also be used by patients who are temporarily voiceless due to a tracheotomy, who have to protect their vocal folds due to illness or who are connected to a respirator.
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
- Yes
- 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 |
|---|---|---|---|---|
| ESE | Larynx, Artificial (Battery-Powered) | Ear, Nose, Throat | 874.3375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34857 | Transcervical artificial larynx | A battery-powered, speech-assistive device designed to be used by a person who has had their larynx removed (laryngectomy) to assist them in the reproduction of sounds similar to those produced by the vocal cords in normal speech. It is an externally-applied electromechanical device (also known as a neck-type artificial larynx) with a plastic or metal probe that generates a sound (i.e., tone); when the probe is held against the tissues of the neck (or cheek) the tone is transmitted to the mouth through the oropharynx. The appropriate movement of the lips, tongue, teeth, and jaw converts the tone into meaningful speech (i.e., modulates the tone). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04040823006502 | GS1 |