AutoDrop

Primary DI
00384706000022
Brand
AutoDrop
Company
OWEN MUMFORD USA INCORPORATED
Model
OP 6000
Device description
AutoDrop Eye Guide
Published
2023-06-07
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
false

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
00384706000022PackageGS120In Commercial Distribution
00384706000039PackageGS110In Commercial Distribution
00384706000015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384706000022003847060000223847060000220384706000022
00384706000039003847060000393847060000390384706000039
00384706000015003847060000153847060000150384706000015

GMDN Terms#

Term, Definition table
TermDefinition
Eye dropper bottle aidA non-sterile device intended to be attached to an eye dropper bottle to assist with the self-administration of an eye irrigation/treatment solution. It is typically a plastic device intended to assist with positioning of the nozzle, focusing of the eye, and/or squeezing of the bottle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803401454
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384701604010Unistik Pro PlusAT 16042025-09-16
00384703160019EmpelvicSM 31602025-08-22
00384703150010EmpelvicSM 31502025-08-22
00384703155015EmpelvicSM 31552025-08-22
00761059640004Unifine OTCAN 36402025-02-14
00761059641001Unifine OTCAN 36412025-02-14
00761059650003Unifine OTCAN 36502025-02-14
00761059651000Unifine OTCAN 36512025-02-14
00761059640028Unifine OTCAN 36402025-02-14
00761059641032Unifine OTCAN 36412025-02-14
00761059650027Unifine OTCAN 36502025-02-14
00761059651031Unifine OTCAN 36512025-02-14
00761059507093Unifine PentipsAN 3550AC2024-05-17
00761059359012Unifine PentipsAN 3590AC2024-02-21
00761059354000Unifine PentipsAN 3540AC2024-02-05
00761059354024Unifine PentipsAN 3540AC2024-02-05
00761059352914Unifine PentipsAN 3529AC2024-01-22
00761059352921Unifine PentipsAN 3529AC2024-01-22
00384707001011Unistik VacuFlipBC 70012023-10-06
00384707102015Unistik VacuFlipBC 71022023-10-06

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
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
00076855700075ApexDrive 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