Identity
- Trade Name
- Disposable Hemodialysis Access Catheter Set FDA UDI
- Generic Name
- Haemodialysis catheterization kit FDA UDI
- Model / Reference
- Double Lumen 6.5F*8cm FDA UDI
Identifiers
- Catalog Number
- FR-2612 FDA UDI
- Primary DI / UDI-DI
- 06938634471573 FDA UDI
- 510(k) Number
- K102833 FDA UDI
- FDA Product Code
- MPB FDA UDI
- GMDN Term
- Haemodialysis catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemodialysis/central venous catheterization kitHaemodialysis catheterization kit
Disposable Hemodialysis Access Catheter Set by Guangdong Baihe Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K102833 also covers:
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Baihe Medical Technology Co., Ltd
Sources (1)
- FDA UDI 02f0b4c9-20c6-4894-afc3-bc587a954dca 34 fields · synced Jun 8, 2026