FDA.reportPublic FDA data

Medline

Primary DI
00193489181923
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPH1550BT
Catalog number
MPH1550BT
Device description
STRIP,GLUCOSE,EVENCARE G2 W/ BLUETOOTH
Published
2023-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBWSystem, test, blood glucose, over the counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212140000GlucoSure Link Blood Glucose Monitoring SystemApex BioTechnology Corp.2022-08-25NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489181927PackageGS1600In Commercial Distribution
00193489181923PrimaryGS10
80193489181929Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019348918192720193489181927
00193489181923001934891819231934891819230193489181923
8019348918192980193489181929

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
Handling Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat. Keep away from sunlight.
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature39 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489135909MEDLINEDYNJP2228SGDYNJP2228SG2026-07-17
10197344112722MEDLINESSBCS23GTSSBCS23GT2026-07-17
10197344157174MEDLINESNAPSECUREPSNAPSECUREP2026-07-17
10197344169450MEDLINEMSCSRG9736MSCSRG97362026-07-17
10197344205141MEDLINEMSC608ASXLMSC608ASXL2026-07-17
10197344216116MEDLINESSBCS21GSSBCS21G2026-07-17
10197344216130MEDLINESSBCS21GTSSBCS21GT2026-07-17
10197344216147MEDLINESSBCS23GSSBCS23G2026-07-17
10197344216154MEDLINESSBCS23GLSSBCS23GL2026-07-17
10197344216161MEDLINESSBCS25GSSBCS25G2026-07-17
10197344216178MEDLINESSBCS25GLSSBCS25GL2026-07-17
10197344216185MEDLINESSBCS25GTSSBCS25GT2026-07-17
10884389362020MEDLINEDYNJSMD01DYNJSMD012026-07-17
10888277407954MEDLINEOR87VOR87V2026-07-17
20193489029939MEDLINEMDTZ1020872GHMDTZ1020872GH2026-07-17
20193489029953MEDLINEMDTZ1020872GJMDTZ1020872GJ2026-07-17
20197344033925MEDLINEMLABDISH35MLABDISH352026-07-17
20197344033956MEDLINEMLABDISH65MLABDISH652026-07-17
20197344219428MEDLINEMDT2168054XGVMDT2168054XGV2026-07-17
20197344219442MEDLINEMDT2168104GVMDT2168104GV2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563841Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563865Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06223015680010Be SureEPS BIO TECHNOLOGY CORP.NBW2026-05-07
06225000563858Be Smart Blood Glucose MeterEPS BIO TECHNOLOGY CORP.NBW2026-05-07
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28