FDA UDI
In Commercial Distribution
🇺🇸 United States
Protocol Administration Set with Small Catheter and Retention Cuff
DI: 10815112021280
·
Model: 390402
·
BRACCO DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Protocol Administration Set with Small Catheter and Retention Cuff
- Primary DI
- 10815112021280
- Version / Model
- 390402
- Catalog Number
- 390402
- Company Name
- BRACCO DIAGNOSTICS INC
- Labeler DUNS
- 849234661
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-29
- Public Version
- 1
- Public Version Date
- 2023-07-07
- Public Version Status
- New
- Public Device Record Key
- 3993f4cd-4f02-47d1-8d14-53ee9d541862
Device Description
Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation
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
- Yes
- 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 |
|---|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38559 | Insufflation gas conditioning tubing set | A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30815112021284 | GS1 | Box | 24 | In Commercial Distribution | |
| Primary | 10815112021280 | GS1 |
Customer Contacts
- Phone
- 609-514-2200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030854 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 20 | French |