FDA.reportPublic FDA data

Apex

Primary DI
00076855700075
Brand
Apex
Company
Drive Devilbiss Healthcare
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCMDropper, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCMDropper, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30076855700076PackageGS1144In Commercial Distribution
00076855700075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685570007630076855700076
00076855700075000768557000750768557000750076855700075

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00384706050010AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706150017AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-20
00384706000015AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00384706000022AutoDropOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00384706100012AutoSqueezeOWEN MUMFORD USA INCORPORATEDKCM2023-06-07
00076855100059ApexDrive Devilbiss HealthcareKCM2023-03-10
00635515992641ApexDrive Devilbiss HealthcareKCM2023-03-10
30076855100050ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
30635515992642ApexCOMPASS HEALTH BRANDS CORP.KCM2023-03-10
00635515992665ApexDrive Devilbiss HealthcareKCM2023-02-15
30041520876479ApexCOMPASS HEALTH BRANDS CORP.KCM2023-02-15
00076855005088ApexDrive Devilbiss HealthcareKCM2023-01-08
00076855700051ApexDrive Devilbiss HealthcareKCM2023-01-08
30076855700076ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855700052ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
30076855005089ApexCOMPASS HEALTH BRANDS CORP.KCM2023-01-08
00076855601051ApexDrive Devilbiss HealthcareKCM2022-12-12
00076855605059ApexDrive Devilbiss HealthcareKCM2022-12-12
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