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	893130	FDA UDI	Class I	Active
CVS Health	376508	FDA UDI	Class II	Active
CVS/Pharmacy	KD-1300	FDA UDI	Class II	Active
Cvs	243909	FDA UDI	N	Active
CVS Health	542630	FDA UDI	Class I	Active
CVS/Pharmacy	KD-121P	FDA UDI	Class II	Active
CVS Health	CVS Health C20	FDA UDI	Class II	Active
Cvs Health	869091_68255CV1	FDA UDI	Class I	Active
CVS Health	950987	FDA UDI	U	Active
CVS Health	875957	FDA UDI	U	Active
CVS Health	631762	FDA UDI	Class II	Active
Cvs Health	127200	FDA UDI	Class I	Active
CVS Health	955542	FDA UDI	Class I	Active
CVS Health	210011	FDA UDI	Class I	Unknown
CVS Pharmacy Inc.	Applicator Super	FDA UDI	Class II	Active
CVS Health	981896	FDA UDI	Class II	Unknown
CVS Health	482019	FDA UDI	Class I	Active
Cvs Health	692440	FDA UDI	Class I	Active
CVS Health	336795	FDA UDI	Class I	Active
CVS Health	SHX	FDA UDI	Class I	Active
CVS Health	865378	FDA UDI	U	Active
CVS Health	554817	FDA UDI	Class II	Active
CVSHealth	BP3KX1-1BCVS	FDA UDI	Class II	Active
CVS Health Tampons	BCVXS18	FDA UDI	Class II	Active
CVS Health Tampons	BCVFS18	FDA UDI	Class II	Unknown
Cvs Health	914226	FDA UDI	Class I	Active
CVS Coverlets Contact Lens Case	68048CV2	FDA UDI	Class II	Active
CVS Health	409172	FDA UDI	Class I	Unknown
CVS Health	Advanced Early Result Pregnancy Test	FDA UDI	Class II	Unknown
Cvs Health	67661BCCV	FDA UDI	Class I	Active
CVS Health Digital Pregnancy Test	CB8	FDA UDI	Class II	Unknown
CVS Health	702514	FDA UDI	Class I	Unknown
CVS Health One Step Pregnancy Test	FPPL	FDA UDI	Class II	Unknown
CVS Health	UQW	FDA UDI	Class I	Active
CVSHealth	BP3MV1-3WCVS	FDA UDI	Class II	Active
CVS Health	336797	FDA UDI	Class I	Active
CVS Health	800231	FDA UDI	Class II	Active
CVS/Pharmacy	KD-121D	FDA UDI	Class II	Active
CVS Health	000831-511-569UC	FDA UDI	Class II	Active
Cvs Health	873584/400844CV	FDA UDI	Class I	Active
CVS Health Tampons	BCVUC34	FDA UDI	Class II	Active
Cvs	8000-10614	FDA UDI	Class II	Unknown
CVS Health	Six Days Sooner Pregnancy Test	FDA UDI	Class II	Active
CVS Health	893125	FDA UDI	Class I	Active
CVS Health	894108	FDA UDI	Class I	Active
CVS Health	376547	FDA UDI	Class I	Active
CVS Health	958067	FDA UDI	Class I	Active
CVS Health	375805	FDA UDI	Class I	Unknown
Cvs Health	274020	FDA UDI	Class I	Active
CVS Health	MHP620SKT	FDA UDI	Class II	Active

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