FDA UDI
In Commercial Distribution
🇺🇸 United States
Anrei
DI: 06926839809246
·
Model: AMH-EV-01
·
Anrei Medical(HZ) Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anrei
- Primary DI
- 06926839809246
- Version / Model
- AMH-EV-01
- Company Name
- Anrei Medical(HZ) Co.,Ltd.
- Labeler DUNS
- 529128653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-07
- Public Version
- 1
- Public Version Date
- 2025-01-15
- Public Version Status
- New
- Public Device Record Key
- 127820da-4aa7-4017-9f7b-fa15c063cb77
Device Description
Single Use Endoscope Valves Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61793 | Endoscope suction valve, reusable | A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06926839809246 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192048 | 000 |