microdot Blood Glucose Test Strips

Primary DI
05060141250035
Brand
microdot Blood Glucose Test Strips
Company
CAMBRIDGE SENSORS LTD
Model
100-50
Device description
microdot Blood gucose test strips for use with micodot Blood glucose meter
Published
2022-04-04
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
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070524000MICRODOT BLOOD GLUCOSE MONITORING SYSTEMCambridge Sensors Limited2007-06-22NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35060141250036PackageGS1150In Commercial Distribution
05060141250035PrimaryGS10
05060141250592Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3506014125003635060141250036
05060141250035050601412500355060141250035
05060141250592050601412505925060141250592

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.

Contacts#

Phone, Email table
PhoneEmail
1-877-374-4062info@microdotcs.com

Regulatory Flags#

DUNS number
770456226
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060141250189microdot xtra blood glucose test strip200-502022-04-04
05060141250493microdot xtra blood glucose test strip200-252022-04-04
05060141250592microdot Blood Glucose Test Strips100-502022-04-04
35060141250180microdot xtra blood glucose test strip200-502022-04-04
35060141250494microdot xtra blood glucose test strip200-252022-04-04
05060141250530microdot xtra meter200-012022-04-04
05060141250554microdot Blood Glucose meter100-012022-04-04

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Primary DI, Brand, Company table
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