FDA.report

Apex

Primary DI
30076855700168
Brand
Apex
Company
COMPASS HEALTH BRANDS CORP.
Model
70016
Device description
Dayplanner
Published
2023-01-08
Public version status
Update
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
30076855700168PackageGS1144In Commercial Distribution
00076855700167PrimaryGS10

GMDN Terms

TermDefinition
Personal pill dose dispenser, manualA portable, hand-held device designed for the manual dispensing of the correct dose(s) of an individual patient's medication pills. It is typically carried and operated by the patient and consists of a small container with covered compartments containing the pills which the patient manually opens to dispense the dose(s); the pills are not included. This dispenser is often labelled with the days of the week and the time of day the medication should be taken.

Sterilization Methods

Method

Contacts

PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
827221698
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
true
No natural rubber latex
false
Sterilization required before use
false

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