FDA.reportPublic FDA data

PRECICHEK AutoCode foil packed test strip

Primary DI
04260236851128
Brand
PRECICHEK AutoCode foil packed test strip
Company
HMD BIOMEDICAL INC.
Model
3L-10-160031
Catalog number
3L-10-160031
Device description
PRECICHEK AutoCode Blood Glucose ACH foil packed test strip
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
04260236851128PackageGS1120In Commercial Distribution
04260236850329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260236851128042602368511284260236851128
04260236850329042602368503294260236850329

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.

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658644174
Device count
1
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
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19