FDA UDI
In Commercial Distribution
🇺🇸 United States
Angioway
DI: 06936733735954
·
Model: LP-P-30-YNP25
·
Lepu Medical Technology (Beijing) Co.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Angioway
- Primary DI
- 06936733735954
- Version / Model
- LP-P-30-YNP25
- Company Name
- Lepu Medical Technology (Beijing) Co.,Ltd.
- Labeler DUNS
- 529853921
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-23
- Public Version
- 3
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- 2570533d-4e83-4d83-a72f-f018b065cd35
Device Description
Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PTL | Wire, Guide, Catheter, Exempt | Cardiovascular | 870.1330 | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | 870.4290 | 2 |
| PTM | Syringe, Balloon Inflation, Exempt | Cardiovascular | 870.1650 | 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 |
|---|---|---|---|---|---|---|
| Package | 16936733735951 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 06936733735954 | GS1 |