FDA UDI
In Commercial Distribution
🇺🇸 United States
Asurys™
DI: 00191506023348
·
Model: M0067971010
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Asurys™
- Primary DI
- 00191506023348
- Version / Model
- M0067971010
- Catalog Number
- M0067971010
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-03
- Public Version
- 1
- Public Version Date
- 2026-04-13
- Public Version Status
- New
- Public Device Record Key
- 4087133d-ed4f-4390-984d-ba34f283a9d7
Device Description
Fluid Management System Single-Use Inflow Tubing Set
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
- 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 |
|---|---|---|---|---|
| LJH | System, irrigation, urological | Gastroenterology, Urology | 876.5130 | 2 |
| HIG | Insufflator, hysteroscopic | Obstetrics/Gynecology | 884.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43415 | Urological irrigation system | An assembly of devices intended for the infusion of sterile fluids (e.g., saline, water) into the ureter and upper urinary tract to irrigate these passageways in a controlled manner during a diagnostic and /or a therapeutic urological procedure; including a urinary tract endoscopic procedure. It typically consists of a mains electricity (AC-powered) pump, tubing, connectors and other items that enable the pressure, temperature, or flow of water to be controlled. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506023348 | GS1 |