FDA.reportPublic FDA data

Safer Lock

Primary DI
00861121000047
Brand
Safer Lock
Company
Gatekeeper Innovation, Inc.
Model
1000092
Device description
Safer Lock with Bottle (Retail Packaging)
Published
2019-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXBDispenser, solid medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXBDispenser, Solid MedicationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861121000047PackageGS16In Commercial Distribution
00861121000092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861121000047008611210000478611210000470861121000047
00861121000092008611210000928611210000920861121000092

GMDN Terms#

Term, Definition table
TermDefinition
Medicine bottle capA sturdy covering designed to close off and seal the top of a medicine bottle providing protection from the external environment. It will typically consist of a plastic cover that may include a glued or cemented liner/seal, e.g., rubber or plastic. Some devices are threaded for screwing on to the bottle. Medicine bottle caps are frequently made with a built-in safety feature locking mechanism making them child proof, e.g., require a push-down/screw action to open. This device is reusable until the contents of the bottle are exhausted.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)209-5044info@saferlockrx.com

Regulatory Flags#

DUNS number
028113963
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456223666JMUJMU DENTAL, INCNXB2026-07-07
00840456223673JMUJMU DENTAL, INCNXB2026-07-07
00194346615179EquateWAL-MART STORES, INC.NXB2026-03-10
00194346615193EquateWAL-MART STORES, INC.NXB2026-03-10
00194346678921EquateDrive Devilbiss HealthcareNXB2026-03-09
00194346615155EquateDrive Devilbiss HealthcareNXB2026-01-20
30194346615156EquateCOMPASS HEALTH BRANDS CORP.NXB2026-01-20
00850068074228TenoviTenovi Co.NXB2026-01-02
00194346134694EquateWAL-MART STORES, INC.NXB2025-11-14
00850068074020TenoviTenovi Co.NXB2025-09-08
00085006807402TenoviTenovi Co.NXB2025-08-29
00850068074525TenoviTenovi Co.NXB2025-08-29
00076855700600ApexDrive Devilbiss HealthcareNXB2025-08-28
40076855700608ApexCOMPASS HEALTH BRANDS CORP.NXB2025-08-28
10827989000527Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989000633Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989000640Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989004037Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
00041520865816ApexDrive Devilbiss HealthcareNXB2024-12-09
00635515992764ApexDrive Devilbiss HealthcareNXB2024-12-09
30041520865817ApexCOMPASS HEALTH BRANDS CORP.NXB2024-12-09
30635515992765ApexCOMPASS HEALTH BRANDS CORP.NXB2024-12-09
00087701190568ApexDrive Devilbiss HealthcareNXB2024-11-14
00087701190599ApexDrive Devilbiss HealthcareNXB2024-11-14
20087701190562ApexCOMPASS HEALTH BRANDS CORP.NXB2024-11-14
20087701190593ApexCOMPASS HEALTH BRANDS CORP.NXB2024-11-14
06970285517286Weekly pill plannerShanghai CareUs Medical Product Co., Ltd.NXB2024-09-19
06970285516876Tablet cutter coupe-piluleShanghai CareUs Medical Product Co., Ltd.NXB2024-08-05
00079642314868CONAIRCONAIR CORPORATIONNXB2024-03-25
00079642317463ConairCONAIR CORPORATIONNXB2024-03-25