Question 1

What types of medical devices does Valu Merchandisers Company manufacture?

Accepted Answer

Valu Merchandisers Company produces a range of medical devices primarily focused on personal health and hygiene. These include unscented and scented menstrual pads and tampons, single-use incontinence pants, and first aid kits containing medicated supplies. Additionally, the company manufactures diagnostic tools like rapid test kits for detecting human chorionic gonadotropin (hCG) and clinical thermometers, including electronic and infrared models for measuring body temperature.

Question 2

Where is Valu Merchandisers Company based?

Accepted Answer

Valu Merchandisers Company is based in the United States. The company’s operations and manufacturing align with U.S. regulatory standards for medical devices.

Question 3

Which regulatory registries list Valu Merchandisers Company’s devices?

Accepted Answer

Valu Merchandisers Company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations by assigning a unique identifier to each device type, helping track and monitor products throughout their lifecycle.

Question 4

How are Valu Merchandisers Company’s devices classified under FDA regulations?

Accepted Answer

Valu Merchandisers Company’s devices fall into different classification categories under FDA regulations. Most of its products are classified as Class I, which typically includes low-risk devices requiring general controls for safety and effectiveness. Some devices, such as diagnostic kits or certain thermometers, are classified as Class II, which involves additional performance standards to ensure their safety and effectiveness. A few devices are listed as non-classifiable (N), meaning they do not fit neatly into Class I or II and may require case-by-case evaluation.

Device	Model / Reference	Registries	Class	Status
Best Choice	BCNBCSUTO14	FDA UDI	Class I	Active
Best Choice	BUSBCSMXR24	FDA UDI	Class I	Active
Best Choice	720	FDA UDI	Class II	Active
Best Choice	BCNBCSMXR18	FDA UDI	Class I	Active
Best Choice Tampons	BAWAC40	FDA UDI	Class II	Active
Best Choice	KI-8160	FDA UDI	Class II	Active
Best Choice Early Result Pregnancy Test	PLPL	FDA UDI	Class II	Unknown
Best Choice Tampons	BAWUR18	FDA UDI	Class II	Active
Best Choice	BUSBCSUWR20	FDA UDI	Class I	Active
Best Choice	BUSBCSUWS20	FDA UDI	Class I	Active
Best Choice Tampons	BAWAP40	FDA UDI	Class II	Active
Best Choice	One Step Pregnancy Test	FDA UDI	Class II	Unknown
Best Choice	BCNBCSMXO20	FDA UDI	Class I	Active
Best Choice Tampons	BAWAS40	FDA UDI	Class II	Active
Best Choice	BCNBCSUTS16	FDA UDI	Class I	Active
Best Choice Tampons	BAWGS18	FDA UDI	Class II	Active
Best Choice	753	FDA UDI	Class II	Active
Best Choice	FUSBCZPLL64	FDA UDI	Class I	Active
Best Choice	BCNBCSUTR18	FDA UDI	Class I	Active
Best Choice One Step Pregnancy Test	FPPL	FDA UDI	Class II	Active
Best Choice	BUSBCSUWS18	FDA UDI	Class I	Active
Best Choice Tampons	BAWAR10	FDA UDI	Class II	Active
Best Choice Tampons	BAWAR40	FDA UDI	Class II	Active
Best Choice	725978	FDA UDI	N	Active
Best Choice	One Step Pregnancy Test	FDA UDI	Class II	Unknown
Best Choice Tampons	BAWGC36	FDA UDI	Class II	Active
Best Choice Tampons	BAWGR20	FDA UDI	Class II	Active
Best Choice	BCNBCSMXO14	FDA UDI	Class I	Active
Best Choice	BCNBCSMXS16	FDA UDI	Class I	Active
Best Choice	BCNBCZPLL54	FDA UDI	Class I	Active
Best Choice Tampons	BAWAS10	FDA UDI	Class II	Active
Best Choice	BUSBCSMXS24	FDA UDI	Class I	Active
Best Choice One Step Pregnancy Test	FPPL	FDA UDI	Class II	Active
Best Choice Tampons	BAWUS18	FDA UDI	Class II	Active
Best Choice	BUSBCSUWR18	FDA UDI	Class I	Active
Best Choice	BUSBCSDMXR24	FDA UDI	Class I	Active
Best Choice	FUSBCSPLL40	FDA UDI	Class I	Active

VALU MERCHANDISERS COMPANY

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