FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Biopsy Valve
DI: 06970401812387
·
Model: MDBV1A0000A
·
Zhejiang Chuangxiang Medical Technology Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Biopsy Valve
- Primary DI
- 06970401812387
- Version / Model
- MDBV1A0000A
- Catalog Number
- 000522
- Company Name
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- Labeler DUNS
- 544434963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-18
- Public Version
- 3
- Public Version Date
- 2022-07-18
- Public Version Status
- Update
- Public Device Record Key
- da470c43-649c-47d4-b57d-dbe27c46f080
Device Description
ClearGuard Disposable Biopsy Valve for Olympus and Fujinon GI Endoscopes
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
- 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 |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60757 | Endoscopic biopsy valve, sterile | A sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26970401814057 | GS1 | Case | 500 | In Commercial Distribution | |
| Package | 16970401814043 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 06970401812387 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173758 | 000 |