FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PART
DI: 06946332803725
·
Model: PUMP-1
·
Chongqing Jinshan Science & Technology (Group) Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PART
- Primary DI
- 06946332803725
- Version / Model
- PUMP-1
- Company Name
- Chongqing Jinshan Science & Technology (Group) Co., Ltd
- Labeler DUNS
- 545245755
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-22
- Public Version
- 2
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- c7753a17-300c-4dca-bb51-32fcd5cbd78b
- Distribution End Date
- 2024-01-01
Device Description
FOOT PEDAL REPLACEMENT PART FOR AVEOPUMP
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58029 | Foot-switch, pneumatic | A gas-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g. a pneumatic surgical saw, pneumatic wire driver, pneumatic surgical power tool system control unit) to which it is connected typically via one or more hoses and which is dependent upon pressurized gas [e.g., medical air, nitrogen (N2)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06946332803732 | GS1 | 10 | Not in Commercial Distribution | 2024-01-01 | |
| Primary | 06946332803725 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210618 | 000 |