FDA UDI
In Commercial Distribution
🇺🇸 United States
InHealth Technologies; Blom-Singer
DI: 00813307010029
·
Model: BE 6010
·
Freudenberg Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InHealth Technologies; Blom-Singer
- Primary DI
- 00813307010029
- Version / Model
- BE 6010
- Company Name
- Freudenberg Medical, LLC
- Labeler DUNS
- 120981337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 9dcbab07-c8f8-4c1d-9945-bb0196f3c87f
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | Ear, Nose, Throat | 874.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44412 | Tracheoesophageal speech valve, non-indwelling | A non-sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy, following wound healing, to provide the patient with voice restoration. It is placed by the trained patient into the fistula. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The user removes this device periodically for cleaning. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813307010029 | GS1 |
Customer Contacts
- Phone
- 800-477-5969
- [email protected]