FDA UDI
In Commercial Distribution
🇺🇸 United States
Y-type Irrigation Set with 3-way Stopcock
DI: 06974880990680
·
Model: 5mm×7mm×600mm
·
Suzhou AcuVu medical technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Y-type Irrigation Set with 3-way Stopcock
- Primary DI
- 06974880990680
- Version / Model
- 5mm×7mm×600mm
- Company Name
- Suzhou AcuVu medical technology Co., Ltd.
- Labeler DUNS
- 705464292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-18
- Public Version
- 1
- Public Version Date
- 2023-12-26
- Public Version Status
- New
- Public Device Record Key
- ea29211a-583f-44f8-b3fc-e92ea1344d9e
Device Description
It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NWW | Hysteroscope Accessories | Obstetrics/Gynecology | 884.1690 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63460 | Fluid transfer tube, general-purpose | A sterile, flexible, blunt tubular device made of plastic materials designed to be used for the manual transfer of several types of medical fluids (e.g., solutions, syrups) between a first container (e.g., a vial) and a second container [e.g., a syringe]; it is not dedicated to a particular type of fluid or clinical procedure. It is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26974880990684 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 06974880990680 | GS1 |
Customer Contacts
- Phone
- 6178344997
- [email protected]