microdot Blood Glucose Test Strips

Primary DI
05060141250592
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
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
770456226
Device count
50
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060141250035microdot Blood Glucose Test Strips100-502022-04-04
05060141250189microdot xtra blood glucose test strip200-502022-04-04
05060141250493microdot xtra blood glucose test strip200-252022-04-04
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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