FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Two Tank Shuttle Valve System
DI: 30815112021703
·
Model: 710602
·
Bracco Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Two Tank Shuttle Valve System
- Primary DI
- 30815112021703
- Version / Model
- 710602
- Catalog Number
- 710602
- Company Name
- Bracco Diagnostics Inc.
- Labeler DUNS
- 849234661
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 2
- Public Version Date
- 2026-04-10
- Public Version Status
- Update
- Public Device Record Key
- 865f372b-c479-43ed-9854-2b63b042fe04
- Distribution End Date
- 2026-04-08
Device Description
Two Tank Shuttle Valve System
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41617 | Gastrointestinal endoscopic insufflator | A mains electricity (AC-powered) device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization (e.g., prevent dew/mist accumulating at the lens) through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. This device may also be referred to as a gas distention system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30815112021703 | GS1 |
Customer Contacts
- Phone
- 609-514-2200
- [email protected]