FDA.report

Health Care Logistics, Inc®

Primary DI
00827989007802
Company
Health Care Logistics, Inc.
Model
21294
Device description
Personal Tablet Crusher with Cap Red
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
092159383
Device count
1
DM exempt
false
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00827989007802PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00827989007802PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
OHYPill Crusher/Cutter1General Hospital880.6430NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
8008481633hcl@GoHCL.com

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