FDA UDI
In Commercial Distribution
🇺🇸 United States
Protocol Colon Insufflator
DI: 10815112020122
·
Model: 390301
·
Bracco Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Protocol Colon Insufflator
- Primary DI
- 10815112020122
- Version / Model
- 390301
- Catalog Number
- 390301
- Company Name
- Bracco Diagnostics Inc.
- Labeler DUNS
- 849234661
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2025-05-26
- Public Version Status
- Update
- Public Device Record Key
- 001d3f2e-34be-405b-838e-30bcc1c340f6
Device Description
Protocol Colon Insufflator
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 30815112020126 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 10815112020122 | GS1 |
Customer Contacts
- Phone
- 609-514-2200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030854 | 000 |