FDA.reportPublic FDA data

GL GoodLife Blood Glucose Test Strip-Foil For Cloudia

Primary DI
00389154000266
Brand
GL GoodLife Blood Glucose Test Strip-Foil For Cloudia
Company
HMD BIOMEDICAL INC.
Model
IG STRIP FOIL
Catalog number
3L-10-810037
Device description
GL GoodLife Blood Glucose Test Strip-Foil For Cloudia
Published
2017-11-14
Public version status
Update
Distribution status
Not 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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131173000FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.2014-09-18NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00389154000495PackageGS1210Not in Commercial Distribution
00389154000266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00389154000495003891540004953891540004950389154000495
00389154000266003891540002663891540002660389154000266

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-855-692-3511Sales@gl-daibetes.com

Regulatory Flags#

DUNS number
658644174
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00868665000052Rosie SmartMeter Professional StripAC-11 Pro-Strip3L-10-16003E2016-12-07
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04260236850619PRECICHEK AutoCode AC3023K-01-16003A3K-01-16003A2020-07-06
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04260236850848FIA Salut vial packed test strip(for Elhenawy)3S-01-1409963S-01-1409962020-07-17

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