FDA UDI
Not in Commercial Distribution
🇺🇸 United States
andorate® Disposable Endoscope Valves Set
DI: 04897106950225
·
Model: GAR004
·
GA Health Company Limited
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- andorate® Disposable Endoscope Valves Set
- Primary DI
- 04897106950225
- Version / Model
- GAR004
- Company Name
- GA Health Company Limited
- Labeler DUNS
- 686908512
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-28
- Public Version
- 3
- Public Version Date
- 2022-04-25
- Public Version Status
- Update
- Public Device Record Key
- 075b248e-5240-42d7-a870-96d4c84c057b
- Distribution End Date
- 2022-01-12
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
- 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 |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60760 | Endoscope channel support kit | A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14897106950222 | GS1 | Box | 50 | Not in Commercial Distribution | 2022-01-12 |
| Primary | 04897106950225 | GS1 | ||||
| Package | 24897106950229 | GS1 | Carton | 4 | Not in Commercial Distribution | 2022-01-12 |