Identity
- Trade Name
- ABLE CENTRAL VENOUS CATHETER FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Model / Reference
- Single Lumen 20G*5cm FDA UDI
Identifiers
- Catalog Number
- FV-1321 FDA UDI
- Primary DI / UDI-DI
- 06938634476042 FDA UDI
- 510(k) Number
- K070451 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Central venous catheterization kit, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
Yes
FDA UDI
Category: Central venous catheterization kit, short-term
Able Central Venous Catheter by Guangdong Baihe Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070451 also covers:
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — Guangdong Baihe Medical Technology Co., Ltd
- ABLE CENTRAL VENOUS CATHETER — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Baihe Medical Technology Co., Ltd
Sources (1)
- FDA UDI c2c4e963-be77-471c-b400-488dcca4cd14 34 fields · synced May 30, 2026