FDA.reportPublic FDA data

Mckesson

Primary DI
20612479197330
Brand
Mckesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
06-R5051-1
Device description
CONTROL, BLD GLUCOSE LEVEL 1 T
Published
2020-08-19
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
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479197330PackageGS11In Commercial Distribution
40612479197341PackageGS124In Commercial Distribution
10612479250434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247919733020612479197330
4061247919734140612479197341
1061247925043410612479250434

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
1
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
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00810079240548Teladoc Health, Inc.Teladoc Health, Inc.NBW2026-02-17
00810079240555Teladoc Health, Inc.Teladoc Health, Inc.NBW2026-02-17
10041260007351TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2026-02-09
00850080988091AUVONUAN HEALTHCARE LIMITEDNBW2026-02-06
00850001462136GOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) METERGOJJI, INC.NBW2026-02-01
00860015091659KetoBMKETOBM USA LLCNBW2026-01-19
00860015091666KetoBMKETOBM USA LLCNBW2026-01-19
00850068074174TenoviTenovi Co.NBW2026-01-02
00850068074266TenoviTenovi Co.NBW2026-01-02
07506555400003Glucheck Self-Monitoring Blood Glucose SystemEPS BIO TECHNOLOGY CORP.NBW2026-01-02
27506555400014Glucheck Blood Glucose Test StripEPS BIO TECHNOLOGY CORP.NBW2026-01-02
00850063675956metene S BLOOD GLUCOSE MONITORING SYSTEMMETENE LIMITEDNBW2025-12-24
10850044118776iHealthIHEALTH LAB INC.NBW2025-12-19
10850044118806iHealthIHEALTH LAB INC.NBW2025-12-19
10856362005156iHealthIHEALTH LAB INC.NBW2025-12-19
00199284201354SureMediks B-ketone & blood glucose monitoring systemRasimo Systems LLCNBW2025-12-05
00816042016066FORAFORA CARE INC.NBW2025-12-05
00883489002662iGlucose Touch Blood Glucose MeterBIONIME CORPORATIONNBW2025-12-04
00883489002686iGlucose Touch Blood Glucose Test StripBIONIME CORPORATIONNBW2025-12-04
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10385540109732CareSens S Fit BTAgaMatrix, Inc.NBW2025-11-30
00050428284391CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
00050428284483CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10075450843573TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2025-11-26
00850068074457TenoviTenovi Co.NBW2025-11-20
20385540109722CareSens S FitAGAMATRIX, INC.NBW2025-08-04