FDA.reportPublic FDA data

CareLiving MM1100 Control Solution For Blood Glucose

Primary DI
00383568100758
Brand
CareLiving MM1100 Control Solution For Blood Glucose
Company
Care Living Diagnostics Inc.
Model
MM1100
Catalog number
83568-1007-58
Device description
CareLiving MM1100 Control Solution
Published
2024-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111456000MEDISIGN BLOOD GLUCOSE MONITORING SYSTEMTianjin Empecs Medical Device Co., Ltd.2012-02-28NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383568100758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383568100758003835681007583835681007580383568100758

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature39.2 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-811-9866service@careliving.com

Regulatory Flags#

DUNS number
125354643
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383568100819CareLiving Blood Glucose Test Strips 100ctCL-10083568-1008-192023-11-15
00383568100857CareLiving Blood Glucose Test Strips 50ct CL-5083568-1008-572023-11-15
00383568101618EZflex Lidocaine 4% pain relief patch 5 count112025-11-04
00383568101625EZflex Lidocaine 4% & Menthol 1% pain relief patch 5 count112025-11-04
00383568300448EasyLife Safety Pen Needles 4MM 31G 100pcsEL340483568-3004-482025-09-18
00383568300455EasyLife Safety Pen Needles 5MM 31G 100pcsEL340583568-3004-552025-09-18
00383568400247EasyLife Mini Safety Pen Needles 4MM 31G 100pcsEL420483568-4002-472025-09-18
00383568400315EasyLife Insulin syringe 30G 1/2” 1cc 100pcsEL-SY0183568-4003-152025-09-18
00383568400322"EasyLife Insulin syringe 31G 5/16"" 1cc 100pcs"EL-SY0383568-4003-222025-09-18
00383568400339"EasyLife Insulin syringe 30G 5/16"" 1cc 100pcs"EL-SY0283568-4003-392025-09-18
00383568400421"EasyLife safety Insulin syringe 29G 1/2"" 1ml/cc 100pcs"EL-SY0483568-4004-212025-09-18
00383568400438EasyLife safety Insulin syringe 30G 1/2” 1/2ml/cc 100pcsEL-SY0583568-4004-382025-09-18
00383568400445"EasyLife safety Insulin syringe 30G 5/16"" 1/2ml/cc 100pcs"EL-SY0783568-4004-452025-09-18
00383568400452EasyLife safety Insulin syringe 30G 1/2” 1ml/cc 100pcsEL-SY0683568-4004-522025-09-18
00383568400469"EasyLife safety Insulin syringe 30G 5/16"" 1ml/cc 100pcs"EL-SY0883568-4004-692025-09-18
00383568400476"EasyLife safety Insulin syringe 31G 5/16"" 1/2ml/cc 100pcs"EL-SY0983568-4004-762025-09-18
00383568400483"EasyLife safety Insulin syringe 31G 5/16"" 1ml/cc 100pcs"EL-SY1083568-4004-832025-09-18
00383568400490"EasyLife safety Insulin syringe 32G 5/16"" 1ml/cc 100pcs"EL-SY1183568-4004-902025-09-18
10383568300445EasyLife Safety Pen Needles 4MM 31G 100pcsEL340483568-3004-482025-09-18
10383568300452EasyLife Safety Pen Needles 5MM 31G 100pcsEL340583568-3004-552025-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
04719869706966medisana BG 150 Blood Glucose MeterTYSON BIORESEARCH INC.NBW2026-08-19
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.NBW2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCNBW2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJX2026-08-13
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30