FDA.report

Medline

Primary DI
10193489102499
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON137000R
Catalog number
NON137000R
Device description
CUTTER/CRUSHER, PILL, BLUE
Published
2022-03-29
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
true

Related Records

Contact Domains

Product Codes

CodeName
NXBDispenser, solid medication
OHYPill crusher/cutter

Product Code Classifications

CodeDeviceSpecialtyClass
NXBDispenser, Solid MedicationPhysical Medicine1
OHYPill Crusher/CutterGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10193489102499PackageGS124In Commercial Distribution
00193489102492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1019348910249910193489102499
00193489102492001934891024921934891024920193489102492

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
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
Sterilization required before use
false

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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
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20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
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20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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00850068074228TenoviTenovi Co.NXB2026-01-02
10810132043656HCSConcordance Healthcare Solutions LLCOHY2025-12-17
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10810132043670HCSConcordance Healthcare Solutions LLCOHY2025-12-17
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00850068074020TenoviTenovi Co.NXB2025-09-08
00085006807402TenoviTenovi Co.NXB2025-08-29
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40076855700608ApexCOMPASS HEALTH BRANDS CORP.NXB2025-08-28
10827989000527Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
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10827989000640Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989003986Health Care Logistics, Inc®Health Care Logistics, Inc.OHY2025-03-13
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