FDA.reportPublic FDA data

PRECICHEK AutoCode vial packed test strip

Primary DI
04260236851159
Brand
PRECICHEK AutoCode vial packed test strip
Company
HMD BIOMEDICAL INC.
Model
3S-01-160037
Catalog number
3S-01-160037
Device description
PRECICHEK AutoCode Blood Glucose ACH vial packed test strip.
Published
2020-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K120064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120064000TEST, BLOOD GLUCOSE SYSTEMHmd Biomedical, Inc.2012-09-05NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260236851241PackageGS1100In Commercial Distribution
04260236851159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260236851241042602368512414260236851241
04260236851159042602368511594260236851159

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04711200724820GL GoodLife 001 blood glucose monitoring system3K-01-25003W3K-01-25003W2026-05-08
04711200724837GL GoodLife 001 Blood Glucose Test Strip3S-01-25003T3S-01-25003T2026-05-08
04711200724844GL GoodLife 001 Glucose Control Solution3C-01-2500373C-01-2500372026-05-08
00389154000266GL GoodLife Blood Glucose Test Strip-Foil For CloudiaIG STRIP FOIL3L-10-8100372017-11-14
00389154000594GL GoodLife Blood Glucose Test StripAC-11 AC302 (vial)3S-01-16003E2016-12-09
00810038634869Easy@Home Blood Glucose Test Strip3S-01-2500383S-01-2500382023-03-15
00810038636061Easy@Home EBG-100BLE blood glucose monitoring system3K-01-25003G3K-01-25003G2024-07-17
00810038636894Easy@Home EBG-100BLE Blood Glucose Test Strip3S-01-25003F3S-01-25003F2024-07-17
00850048540491LPOW blood glucose monitoring system(Meter)3K-01-25003E3K-01-25003E2023-09-28
00850048540507LPOW Blood Glucose Test Strip3S-01-25003E3S-01-25003E2023-09-28
00868665000052Rosie SmartMeter Professional StripAC-11 Pro-Strip3L-10-16003E2016-12-07
04260236850244FIA Salut CS063K-01-14003163K-01-14003162020-07-06
04260236850329PRECICHEK AutoCode foil packed test strip3L-10-1600313L-10-1600312020-07-01
04260236850367FIA Salut foil packed test strip3L-10-1400333L-10-1400332020-07-08
04260236850411PRECICHEK AutoCode vial packed test Strip3S-01-1600323S-01-1600322020-05-12
04260236850459FIA Salut foil packed test strip(for SS)3L-10-14003A3L-10-14003A2020-07-17
04260236850466FIA Salut vial packed test strip3S-01-14003353S-01-14003352020-07-06
04260236850480FIA Salut vial packed test strip3S-01-14003343S-01-14003342020-07-08
04260236850619PRECICHEK AutoCode AC3023K-01-16003A3K-01-16003A2020-07-06
04260236850664PRECICHEK AutoCode foil packed test strip3L-10-16003D3L-10-16003D2020-07-06

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Primary DI, Brand, Company table
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