FDA.report

CVS HEALTH

Primary DI
10050428636098
Brand
CVS HEALTH
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
67767BCCV
Device description
BC CVS DELUXE TABLET CUTTER
Published
2020-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OHYPill Crusher/Cutter

Product Code Classifications

CodeDeviceSpecialtyClass
OHYPill Crusher/CutterGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10050428636098PackageGS1250In Commercial Distribution
00050428636091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042863609810050428636098
00050428636091000504286360910504286360910050428636091

GMDN Terms

TermDefinition
Pill crusher/splitterA hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
952-890-1940udi@apothecaryproducts.com

Regulatory Flags

DUNS number
062312574
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10
00050428005897CVS 695560XL cuff2025-12-10
10050428005832CVS 695534BM222025-12-09
10050428005856CVS 695537BM432025-12-09
10842942017541CVS4608662025-12-08

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