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	800231	FDA UDI	Class II	Active
CVSHealth	BPAG1-20CVS	FDA UDI	Class II	Active
CVS Health	BCVPR36	FDA UDI	Class II	Unknown
CVS Health	HTD8220	FDA UDI	Class II	Active
CVS Health	950987	FDA UDI	Class I	Unknown
CVS Health	One Step Pregnancy Test	FDA UDI	Class II	Unknown
CVS Health	209995	FDA UDI	Class I	Active
CVS Health At Home A1C Test Kit	3059	FDA UDI	Class II	Active
CVS Health	445417	FDA UDI	U	Active
Cvs	460866	FDA UDI	Class I	Active
CVS Health	001917-715-CVSU	FDA UDI	Class I	Active
CVS Health	235502	FDA UDI	Class I	Active
CVS Health	216515	FDA UDI	Class I	Unknown
Cvs Health	245997	FDA UDI	Class I	Active
CVS Health	894096	FDA UDI	Class I	Unknown
CVS Health	953436	FDA UDI	Class I	Active
CVS Health	BP3KQ1-1ECVS	FDA UDI	Class II	Active
CVS Health Tampons	BCVUS18+	FDA UDI	Class II	Active
CVS Health	BCVHC18	FDA UDI	Class II	Active
CVS Health	241628	FDA UDI	Class I	Active
CVS Health	958070	FDA UDI	Class I	Active
CVS Health	998839	FDA UDI	Class I	Active
CVS Health	893132	FDA UDI	Class I	Active
Cvs Health	274016	FDA UDI	Class I	Active
CVS Health	672044	FDA UDI	Class I	Active
CVS Health	CVS991272MYV1	FDA UDI	Class I	Active
Cvs Health	688186	FDA UDI	Class I	Active
CVS Health	One Step Pregnancy Test	FDA UDI	Class II	Unknown
CVS Health Tampons	BCVGL18	FDA UDI	Class II	Active
Cvs Health	PS12EBCCV	FDA UDI	Class I	Active
CVS Health	959039	FDA UDI	Class I	Active
CVS Soft Grip Contact Lens Case	68012CV1	FDA UDI	Class II	Active
CVS Health	687637	FDA UDI	Class I	Unknown
Cvs	GWM700	FDA UDI	Class I	Active
CVS Health Tampons	BCVSGR20	FDA UDI	Class II	Active
CVS Health	One Step Pregnancy Test	FDA UDI	Class II	Unknown
CVS Health	482017	FDA UDI	Class I	Unknown
CVS Health	UVH	FDA UDI	Class I	Active
CVS Pharmacy Inc.	Applicator Super Plus	FDA UDI	Class II	Active
CVS Health	376551	FDA UDI	Class I	Unknown
CVS Health	270360	FDA UDI	Class I	Active
CVS Health	Early Result & Digital Pregnancy Test Kit	FDA UDI	Class II	Unknown
CVS Health	375786	FDA UDI	Class I	Unknown
CVS Health	762161	FDA UDI	Class I	Active
CVS Health	UGN	FDA UDI	Class I	Active
CVS Pharmacy Inc.	Applicator Super Plus	FDA UDI	Class II	Active
CVS Health	444843	FDA UDI	Class I	Active
CVS Health	964606	FDA UDI	Class I	Active
CVS Health Early Pregnancy Test	PLPL	FDA UDI	Class II	Unknown
Cvs Health Tampons	10004391	FDA UDI	Class II	Active

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