IMPROSAFE® Blood Collection Set with Pre-Attached Holder

FDA UDI

Class II (US FDA UDI)

by Guangzhou Improve Medical Instruments Co., Ltd.

Identity

Trade Name: IMPROSAFE® Blood Collection Set with Pre-Attached Holder FDA UDI
Generic Name: Blood collection set, invasive FDA UDI
Model / Reference: 27G×2/5”×12” FDA UDI

Identifiers

Catalog Number: 596127302 FDA UDI
Primary DI / UDI-DI: 06974481831054 FDA UDI
510(k) Number: K153388 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Blood collection set, invasive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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

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

Yes

FDA UDI

Category: Blood collection set, invasive

IMPROSAFE® Blood Collection Set with Pre-Attached Holder by Guangzhou Improve Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K153388 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: Guangzhou Improve Medical Instruments Co., Ltd.

Sources (1)

FDA UDI b014a9ff-79e8-4670-9237-fca4d6be4947 34 fields · synced Jun 1, 2026