FDA.reportPublic FDA data

McKesson

Primary DI
20612479197255
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
06-R3051P-01
Device description
STRIPS, BLD GLUC TRUEMETRIX PR
Published
2016-12-09
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
true

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479197255PrimaryGS10
00612479219854Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061247919725520612479197255
00612479219854006124792198546124792198540612479219854

GMDN Terms#

Term, Definition table
TermDefinition
Home-use blood glucose spot-check analysis systemA portable, mains electricity (AC-powered) device assembly, with a rechargeable battery, intended to electronically measure and display blood glucose concentration for intermittent spot-check measuring. It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the spot-check/trending measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and other associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003164549RosieSouthern Life Systems, Inc.LFR2026-03-02
10840330705698TRUE METRIX PROTRIVIDIA HEALTH, INC.LFR2025-12-02
40612479280494McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
40612479280548McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
00850014861629HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX)Hearts Bio, Inc.LFR2025-03-31
40301939628029CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2025-01-06
00847713000800microdot® Pro Test Strips (25ct)Cambridge Sensors USA LLCLFR2024-10-30
00847713000817microdot® Pro Test Strips (50ct)Cambridge Sensors USA LLCLFR2024-10-30
80816042015034FORAFORA CARE INC.LFR2024-10-01
00860012134021Blood Glucose Test Strips (50pcs/box) LIVE TULATULA HEALTH, INC.LFR2024-06-14
20353885012830OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2024-01-31
00860009958029DIABIMETRICS Blood Glucose Test Strips (50PCS)Health For Mankind CompanyLFR2024-01-23
10850044118257iHealthIHEALTH LAB INC.LFR2023-08-30
10850044118264iHealthIHEALTH LAB INC.LFR2023-08-30
10850044118202iHealthIHEALTH LAB INC.LFR2023-08-24
20353885012793OneTouch Verio FlexLifeScan Europe GmbHLFR2023-05-26
00860313000933Oh'Care LiteIJDREAM CORPORATIONLFR2023-03-31
00894030002277EmbraceWAVE+ Pre-Pack (3x24)OMNIS HEALTH, LLCLFR2023-03-23
00894030002598HealthWise Embrace TALK Pre-Pack (3x15)OMNIS HEALTH, LLCLFR2022-10-27
20353885012106OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
20353885012625OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
20353885012632OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
20353885012489OneTouch Verio FlexLifeScan Europe GmbHLFR2022-05-19
05060141250592microdot Blood Glucose Test StripsCAMBRIDGE SENSORS LTDLFR2022-04-04
35060141250180microdot xtra blood glucose test stripCAMBRIDGE SENSORS LTDLFR2022-04-04
35060141250494microdot xtra blood glucose test stripCAMBRIDGE SENSORS LTDLFR2022-04-04
40301937828018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2022-01-07
40301939550016CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-12-08
40301937825017CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-11-22
00894030002611Embrace Blood Glucose MonitorOMNIS HEALTH, LLCLFR2021-09-23