DEFENDO
- Primary DI
- 50724995228953
- Brand
- DEFENDO
- Company
- MEDIVATORS INC.
- Model
- Defendo Fujifilm 700 Series
- Catalog number
- 100335
- Device description
- Defendo for Fuji 700, 3-piece Single Use Valve Kit with Air Water, Suction, and Biopsy Valve.
- Published
- 2024-01-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
medivators.comProduct Codes
| Code | Name |
|---|---|
| ODC | Endoscope channel accessory |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K232329 | 000 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K232329 | 000 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | Medivators (A Subsidiary of Steris Corporation) | 2023-12-21 | ODC |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 50724995228953 | Package | GS1 | 50 | In Commercial Distribution |
| 00724995228958 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 50724995228953 | 50724995228953 | ||
| 00724995228958 | 00724995228958 | 724995228958 | 0724995228958 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(800)444-4729 | custserv@MEDIVATORS.com |
Regulatory Flags
- DUNS number
- 068199363
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00677964153662 | Endo Carry-on Procedure Kit | 4011245 | 4011245 | 2026-05-26 |
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| 00677964153730 | Endo Carry-on Procedure Kit | 4011239 | 4011239 | 2026-05-26 |
| 00677964153747 | Endo Carry-on Procedure Kit | 4011251 | 4011251 | 2026-05-26 |
| 00677964153754 | Endo Carry-on Procedure Kit | 4011253 | 4011253 | 2026-05-26 |
| 00677964153761 | Endo Carry-on Procedure Kit | 4011254 | 4011254 | 2026-05-26 |
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