FDA UDI
In Commercial Distribution
🇺🇸 United States
FUJIFILM
DI: 04547410313338
·
Model: SB-604
·
FUJIFILM CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FUJIFILM
- Primary DI
- 04547410313338
- Version / Model
- SB-604
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-07
- Public Version
- 3
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- 52c73393-2734-49fb-8e5f-180fc5c2722f
Device Description
This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to suck air in the body cavity as well as to feed water into the balloon. Do not use this product for any other purpose.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, High-level Disinfectant, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFY | Adaptor, bulbs, miscellaneous, for endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61793 | Endoscope suction valve, reusable | A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24547410313332 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 04547410313338 | GS1 |
Customer Contacts
- Phone
- +018002728465
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- There must be no condensation.
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius