Multi-Sample Blood Collection Set

FDA UDI

Class II (US FDA UDI)

by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Identity

Trade Name: Multi-Sample Blood Collection Set FDA UDI
Generic Name: Blood collection set, invasive FDA UDI
Device Name: A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device. FDA UDI
Model / Reference: 25G X 3/4" FDA UDI
Description: A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device. FDA UDI

Identifiers

Catalog Number: MER2025 FDA UDI
Primary DI / UDI-DI: 06958697607221 FDA UDI
510(k) Number: K202188 FDA UDI
FDA Product Code: JKA FDA UDI
GMDN Term: Blood collection set, invasive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood collection set, invasive

Multi-Sample Blood Collection Set by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202188 also covers:

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: Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Sources (1)

FDA UDI 3bf78351-14d0-4a32-aeb2-62d50cb7c5f0 35 fields · synced May 30, 2026