FDA UDI
In Commercial Distribution
🇺🇸 United States
GENTEC®
DI: 06970966663448
·
Model: 880VS-760-00-A-00
·
GENTEC(SHANGHAI)CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GENTEC®
- Primary DI
- 06970966663448
- Version / Model
- 880VS-760-00-A-00
- Company Name
- GENTEC(SHANGHAI)CORPORATION
- Labeler DUNS
- 545287658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-25
- Public Version
- 1
- Public Version Date
- 2022-08-02
- Public Version Status
- New
- Public Device Record Key
- b4159857-4e9c-4256-843b-4c1f1390862b
- Distribution End Date
- 2032-07-25
Device Description
880VS series medical suction kit is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction.
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDP | Regulator, Vacuum | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63650 | General-purpose surgical suction system, pneumatic | An assembly of pneumatically-powered devices, which includes a surgically invasive component, designed to aspirate debris/tissues/fluids from body cavities/wounds during a surgical procedure; it may in addition have non-surgical applications. It is connected to the wall outlet of a compressed gas (e.g., air, oxygen) supply whereby positive gas pressure is converted into negative pressure/suction (the Venturi principle). The system includes a pneumatic suction regulator which controls the degree of negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970966663448 | GS1 |