FDA.reportPublic FDA data

CVS HEALTH

Primary DI
00050428387443
Brand
CVS HEALTH
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
715533-69755CV1
Device description
MEDICAL LIGHT & SCOPE
Published
2020-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXFSpeculum, Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXFSpeculum, IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10050428387440PackageGS124In Commercial Distribution
00050428387443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042838744010050428387440
00050428387443000504283874430504283874430050428387443

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directAn electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.

Contacts#

Phone, Email table
PhoneEmail
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
062312574
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428005873CVS695540BC332025-11-19
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811117106INKAThe Trustee for KAISER FAMILY TRUSTFXF2025-12-01
10097604712429Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXF2022-10-28
00025715697550EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
20025715697554EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
10050428387440CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXF2020-07-29
04987669101049DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101070DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101018DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-27