FDA.report

Medline

Primary DI
10888277705227
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON137000
Catalog number
NON137000
Device description
CUTTER/CRUSHER, PILL, BLUE
Published
2021-09-17
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
OHYPill crusher/cutter

Product Code Classifications

CodeDeviceSpecialtyClass
OHYPill Crusher/CutterGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277705224PrimaryGS10
10888277705227Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827770522420888277705224
1088827770522710888277705227

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
6
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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10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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