FDA UDI
In Commercial Distribution
🇺🇸 United States
Erbe ECO2 plus
DI: 05391536920364
·
Model: 2N100-068
·
PALLIARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Erbe ECO2 plus
- Primary DI
- 05391536920364
- Version / Model
- 2N100-068
- Company Name
- PALLIARE LIMITED
- Labeler DUNS
- 985710055
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-31
- Public Version
- 1
- Public Version Date
- 2024-08-08
- Public Version Status
- New
- Public Device Record Key
- 0e03af0c-071a-46b9-bb4c-0fb2be68d86f
- Distribution End Date
- 2099-07-31
Device Description
CO2 Insufflator
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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 05391536920364 | GS1 |
Customer Contacts
- Phone
- 800-778-3723
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230474 | 000 |