Question 1

What types of medical devices does Woonsocket Prescription Center, Incorporated manufacture?

Accepted Answer

Woonsocket Prescription Center, Incorporated produces a range of medical devices primarily focused on personal hygiene and minor wound care. Their portfolio includes unscented menstrual tampons and pads, adhesive bandages, non-woven gauze pads, and intermittent electronic patient thermometers. They also manufacture skin-cover adhesive strips (both antimicrobial and non-antimicrobial) and electric pad heating systems designed for localized-body heating. These devices are developed to address common health and comfort needs.

Question 2

Where is Woonsocket Prescription Center, Incorporated based, and what regulatory requirements do they follow?

Accepted Answer

Woonsocket Prescription Center, Incorporated is based in the United States. As a manufacturer, they must comply with U.S. regulatory requirements applicable to their device categories, including those set by the FDA. Their products fall under classifications such as Class I, Class II, and unclassified (N/U), meaning they are subject to varying levels of oversight depending on their risk profile and intended use.

Question 3

Are the devices manufactured by Woonsocket Prescription Center, Incorporated listed in any regulatory registries?

Accepted Answer

Yes, the devices produced by Woonsocket Prescription Center, Incorporated are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for devices classified as Class I, Class II, or unclassified (N/U), allowing healthcare providers, regulators, and patients to access standardized identification information for these products.

Question 4

How are the devices from Woonsocket Prescription Center, Incorporated classified by the FDA?

Accepted Answer

The devices manufactured by Woonsocket Prescription Center, Incorporated are classified under three categories: Class I, Class II, and unclassified (N/U). Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls. Unclassified (N/U) devices are either not yet classified or fall outside standard FDA classification frameworks, meaning their regulatory pathway depends on their specific risk and purpose.

Device	Model / Reference	Registries	Class	Status
CVS Health	162619	FDA UDI	Class I	Active
CVS Health	Advanced One Step Pregnancy Test	FDA UDI	Class II	Active
CVS Health One Step Pregnancy Test	FPPL	FDA UDI	Class II	Unknown
CVS Pharmacy Inc	186090	FDA UDI	Class II	Active
CVS Health	830970	FDA UDI	Class I	Active
CVS Health	CVS Health C20	FDA UDI	Class II	Active
CVS Health Tampons	BCVGS18	FDA UDI	Class II	Active
CVS Health	Digital Wide-Tip & Advanced Early Result Pregnancy Tests	FDA UDI	Class II	Active
CVS Health	482017	FDA UDI	U	Active
CVS Health	351297	FDA UDI	Class I	Active
Cvs Health	165549	FDA UDI	Class I	Active
CVS Health	MHP817SLL	FDA UDI	Class II	Active
Cvs Health	715079_71091CV	FDA UDI	Class I	Active
CVS Health	BCVPS36	FDA UDI	Class II	Unknown
CVS Health	MD300C205	FDA UDI	Class II	Active
CVS Health	Six Days Sooner Pregnancy Test	FDA UDI	Class II	Active
4.5 oz Silkie Smooth Personal Lubricant	796140	FDA UDI	Class II	Active
CVS Health	894077	FDA UDI	Class I	Active
CVS Pharmacy Inc	Applicator Regular	FDA UDI	Class II	Active
Cvs Health	872912	FDA UDI	Class I	Active
CVS Health	935686	FDA UDI	Class I	Active
CVS Health	DET-5000	FDA UDI	Class II	Active
CVS Health	MEP300R	FDA UDI	Class II	Unknown
CVSHealth	BP3KY1-3BCVS	FDA UDI	Class II	Active
CVS Health	351295	FDA UDI	Class I	Active
CVS Health	277812	FDA UDI	N	Active
CVS Health	275172	FDA UDI	Class II	Active
CVS Health	865378	FDA UDI	Class I	Active
CVS Health	955729	FDA UDI	Class I	Active
CVS Health	959038	FDA UDI	Class I	Active
CVS Health	875956	FDA UDI	U	Active
CVSHealth	BP3MV1-3WCVS	FDA UDI	Class II	Active
CVSHealth	BP3MY1-2E CVS (800824)	FDA UDI	Class II	Active
CVS Health Tampons	BCVGS16	FDA UDI	Class II	Active
CVS Health	615637	FDA UDI	Class I	Active
CVS Health	444830	FDA UDI	Class I	Active
Cvs Health	273951	FDA UDI	Class I	Active
CVS Health	881264	FDA UDI	Class II	Active
CVS Health	851562	FDA UDI	Class II	Active
Cvs Health	688193	FDA UDI	Class I	Active
CVS Health	Digital Pregnancy Test	FDA UDI	Class II	Unknown
CVS Health	SUV	FDA UDI	Class I	Active
CVS Health	551814	FDA UDI	Class I	Active
CVS Health	789276	FDA UDI	Class I	Unknown
CVS Health Early Result Pregnancy Test	PLPL	FDA UDI	Class II	Unknown
CVS Health	364080	FDA UDI	N	Unknown
CVS Health Tampons	BCVGR18	FDA UDI	Class II	Active
CVS Health	376547	FDA UDI	Class I	Active
CVSHealth	BPAG1-20CVS	FDA UDI	Class II	Active
CVS Health	KI-8360HD.CVS	FDA UDI	Class II	Active

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