FDA.report

Karie

Primary DI
00628678742017
Brand
Karie
Company
AceAge Inc
Model
K01v1
Device description
Karie, in partnership with a Karie authorized Pharmacy, is a smart pill companion that delivers, reminds, connects and secures your medication to promote medication adherence.
Published
2022-02-21
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

Product Codes

CodeName
NXBDispenser, Solid Medication

Product Code Classifications

CodeDeviceSpecialtyClass
NXBDispenser, Solid MedicationPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10628678742007PackageGS14In Commercial Distribution
00628678742017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1062867874200710628678742007
00628678742017006286787420176286787420170628678742017

GMDN Terms

TermDefinition
Personal pill dose dispenser, electricAn electrically-powered device designed to automatically dispense the correct dose of an individual patient’s medication pills at specified times. It is typically a computerized, programmable, tabletop unit loaded with the patient’s pills; the pills are not included. The device is intended to be operated by laypersons and healthcare providers. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity50 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
200688792
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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