FDA UDI
In Commercial Distribution
🇺🇸 United States
LT Connector 1O
DI: 00816185001158
·
Model: T9-CON-1O
·
Torvan Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LT Connector 1O
- Primary DI
- 00816185001158
- Version / Model
- T9-CON-1O
- Catalog Number
- T9-CON-1O
- Company Name
- Torvan Medical Inc
- Labeler DUNS
- 200280404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-28
- Public Version
- 1
- Public Version Date
- 2025-05-06
- Public Version Status
- New
- Public Device Record Key
- c9e7b3af-5ab2-430d-8c44-1683d0784117
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
- 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 |
|---|---|---|---|---|
| FCY | Bulb, Inflation, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37006 | Invasive medical device leak tester, electrical | An electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816185001158 | GS1 |