FDA UDI
In Commercial Distribution
🇺🇸 United States
Blom-Singer
DI: 10850057368021
·
Model: EL 1002
·
Ent Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Blom-Singer
- Primary DI
- 10850057368021
- Version / Model
- EL 1002
- Company Name
- Ent Solutions LLC
- Labeler DUNS
- 125823980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-18
- Public Version
- 1
- Public Version Date
- 2023-12-26
- Public Version Status
- New
- Public Device Record Key
- 790bd0f4-6b4c-400f-815c-f7170c4b4e53
Device Description
Electrolarynx Oral Adapter
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20850057368028 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10850057368021 | GS1 | ||||
| Package | 30850057368025 | GS1 | 12 | In Commercial Distribution |