FDA UDI
In Commercial Distribution
🇺🇸 United States
Balloon Catheter Syringe Pump
DI: 06938695537782
·
Model: FG4013
·
Shanghai Kinetic Medical Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Balloon Catheter Syringe Pump
- Primary DI
- 06938695537782
- Version / Model
- FG4013
- Catalog Number
- FG4013
- Company Name
- Shanghai Kinetic Medical Co., Ltd.
- Labeler DUNS
- 528198569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-31
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 7e9cd2c6-aa41-4844-a684-4619e8e31667
Device Description
Balloon Catheter Syringe Pump, Tube Length 60cm
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17541 | Catheter/overtube balloon inflator, single-use | A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06938695537782 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113742 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius