FDA UDI
In Commercial Distribution
🇺🇸 United States
FUJIFILM
DI: 04547410331561
·
Model: B20UR
·
FUJIFILM CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- FUJIFILM
- Primary DI
- 04547410331561
- Version / Model
- B20UR
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2023-12-11
- Public Version Status
- Update
- Public Device Record Key
- 697122c0-38fb-4a96-9300-48f16330f5e8
Device Description
This product is a balloon for containing the ultrasonic transmitting medium to be used in combination with Fujinon/Fujifilm ultrasonic endoscope EG-530UR in a medical facility under the supervision of a physician. Do not use the product for any other purpose. This product is not intended to be used for children or infants.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODG | Endoscopic ultrasound system, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45712 | Gastrointestinal/biliary dilation balloon catheter | A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547410331561 | GS1 | ||||
| Unit of Use | 84547410331567 | GS1 | ||||
| Package | 14547410331568 | GS1 | Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +018002728465
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120446 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- There must be no condensation.
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius