FDA.report

Apex

Primary DI
30076855700076
Brand
Apex
Company
COMPASS HEALTH BRANDS CORP.
Model
70007
Device description
Medicine Dropper
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

Contact Domains

Product Codes

CodeName
KCMDropper, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCMDropper, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30076855700076PackageGS1144In Commercial Distribution
00076855700075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685570007630076855700076
00076855700075000768557000750768557000750076855700075

GMDN Terms

TermDefinition
Oral medicine dropperA device designed for aspirating a small volume of liquid medicine so that it can be dispensed in single drops into a patient's mouth, typically an infant or small child. It is typically designed as a hollow tube, open at both ends, with an aspiration bulb attached to the proximal end and a narrow opening at the distal end. It is usually made of glass or plastic with a rubber teat. This is a reusable device.

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
false
No natural rubber latex
false
Sterilization required before use
false

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00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00384706050010AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706150017AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706000022AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00384706100012AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
30076855100050ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
30635515992642ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
30041520876479ApexCOMPASS HEALTH BRANDS CORP.KCM2023-02-15
30076855700052ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855005089ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855601052ApexCOMPASS HEALTH BRANDS CORP.KCM2022-12-12
30076855605050ApexCOMPASS HEALTH BRANDS CORP.KCM2022-12-12
00385640005524INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640005838INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640005883INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640005937INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640005982INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640006033INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640013437INSTRUSAFESUMMIT MEDICAL, INC.KCM2021-05-18
00385640005531INSTRUSAFESUMMIT MEDICAL, INC.KCM2017-11-10