FUJIFILM
- Primary DI
- 04547410331004
- Brand
- FUJIFILM
- Company
- FUJIFILM CORPORATION
- Model
- EG-450D5
- Device description
- This product is a medical Endoscope for the upper digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophag
- Published
- 2016-12-14
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FDS | Gastroscope and accessories, flexible/rigid |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 14547410331001 | Package | GS1 | 1 | In Commercial Distribution |
| 04547410331004 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 14547410331001 | 14547410331001 | |
| 04547410331004 | 04547410331004 | 4547410331004 |
GMDN Terms
| Term | Definition |
|---|
| Flexible video gastroduodenoscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It can be end-viewing (looking forward) or side-viewing (looking to one side) and is used for the cannulation of the pancreas and bile duct. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 30 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | There must be no condensation. |
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 30 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide;High-level Disinfectant |
Contacts
| Phone | Email |
|---|
| +018002728465 | xxx@xxx.xxx |
Regulatory Flags
- DUNS number
- 713565195
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| Primary DI | Brand | Model | Catalog | Published |
|---|
| 04547410480269 | FUJIFILM | VS-1000 | | 2026-05-22 |
| 04547410529128 | FUJIFILM | EG-S100XT | | 2026-05-22 |
| 04573596200865 | APERTO Lucent | MR-JCR-82 | Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT | 2026-05-22 |
| 04573596200889 | APERTO Lucent | MR-JC-81 | Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et | 2026-05-22 |
| 04573596200896 | APERTO Lucent | MR-JCR-83 | Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT | 2026-05-22 |
| 04573596200902 | APERTO Lucent | MR-CSC-81 | C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et | 2026-05-22 |
| 04573596200940 | APERTO Lucent | MR-QWC-81 | Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter | 2026-05-22 |
| 04573596200964 | APERTO Lucent | MR-MSC-81 | Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E | 2026-05-22 |
| 04573596200971 | APERTO Lucent | MR-QRC-81 | Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E | 2026-05-22 |
| 04573596201480 | APERTO Lucent | MR-QHC-81R | QD Head coil R MR-QHC-81R for APERTO Lucent | 2026-05-22 |
| 04573596201497 | APERTO Lucent | MR-QKC-83R | QD Knee coil R MR-QKC-83R for APERTO Lucent | 2026-05-22 |
| 04573596201503 | APERTO Lucent | MR-IBC-83 | Open body coil MR-IBC-83 for APERTO Lucent/APERTO | 2026-05-22 |
| 04573596202210 | APERTO Lucent | MR-QFC-82N | Flexible Body coil N(M) MR-QFC-82N for APERTO Luce | 2026-05-22 |
| 04573596202227 | APERTO Lucent | MR-QFC-83N | Flexible Body coil N(L) MR-QFC-83N for APERTO Luce | 2026-05-22 |
| 04547410571134 | FDR AQRO | DR-XD 1000 MBL ES US E | | 2026-03-20 |
| 14547410566250 | FUJIFILM | DH-084STR | | 2026-02-27 |
| 14547410566298 | FUJIFILM | DH-094STR | | 2026-02-27 |
| 14547410566335 | FUJIFILM | DH-104STR | | 2026-02-27 |
| 14547410566373 | FUJIFILM | DH-114STR | | 2026-02-27 |
| 14547410566410 | FUJIFILM | DH-124STR | | 2026-02-27 |
Other Devices Sharing Product Codes
xxx.xxx