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Able Central Venous Catheter Double Lumen 8F*05cm

FDA UDI

Class II (US FDA UDI)

by Guangdong Baihe Medical Technology Co., Ltd

Identity

Trade Name
Able Central Venous Catheter Double Lumen 8F*05cm FDA UDI
Generic Name
Centrally-inserted central venous catheter FDA UDI
Model / Reference
02L-FV-2821 FDA UDI

Identifiers

Primary DI / UDI-DI
06938634490260 FDA UDI
510(k) Number
K070451 FDA UDI
FDA Product Code
FOZ FDA UDI
GMDN Term
Centrally-inserted central venous catheter 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

Yes

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: Centrally-inserted central venous catheter

Able Central Venous Catheter Double Lumen 8F*05cm by Guangdong Baihe Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Centrally-inserted central venous catheter.

Cleared under the same submission

K070451 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guangdong Baihe Medical Technology Co., Ltd

Sources (1)

  • FDA UDI ea1a067f-9fc9-4d46-b191-2a7f4bcd2375 33 fields · synced May 30, 2026