FDA.report

McKesson

Primary DI
20612479197293
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
06-R3051-41
Device description
STRIPS, BLD GLUC TRUEMETRIX SN
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

Related Records

Product Codes

CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications

CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20612479197293PrimaryGS10
00612479219861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2061247919729320612479197293
00612479219861006124792198616124792198610612479219861

GMDN Terms

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

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

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20612479283194McKessonM-8699G2026-05-26
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20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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