FDA UDI
In Commercial Distribution
🇺🇸 United States
OrcaPod™
DI: 08714729981572
·
Model: SUV-629
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OrcaPod™
- Primary DI
- 08714729981572
- Version / Model
- SUV-629
- Catalog Number
- SUV-629
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-22
- Public Version
- 1
- Public Version Date
- 2018-11-22
- Public Version Status
- New
- Public Device Record Key
- da2017cf-b35c-47c6-964d-92ec5da899de
Device Description
Single Use Air/Water, Suction and Biopsy Valve Set with Water Jet Connector
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope channel accessory | Gastroenterology, Urology | 876.1500 | 2 |
| OCX | endoscopic irrigation/suction system | Gastroenterology, Urology | 876.1500 | 2 |
| FEQ | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60760 | Endoscope channel support kit | A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729981589 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 08714729981572 | GS1 |