FDA UDI
In Commercial Distribution
🇺🇸 United States
InHealth Technologies; Blom-Singer
DI: 00813307011507
·
Model: BE 3290
·
Freudenberg Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
90
Basic Information
- Brand Name
- InHealth Technologies; Blom-Singer
- Primary DI
- 00813307011507
- Version / Model
- BE 3290
- Company Name
- Freudenberg Medical, LLC
- Labeler DUNS
- 120981337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 90
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 973f98a4-3477-4e8a-931f-5dfac923dfcf
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 62134 | Tracheoesophageal device insertion capsule | A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813307011507 | GS1 | ||||
| Unit of Use | 00848253002439 | GS1 |
Customer Contacts
- Phone
- 800-477-5969
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry; Keep Away From Sunlight