FIA Salut foil packed test strip(for SS)

Primary DI
04260236851289
Brand
FIA Salut foil packed test strip(for SS)
Company
HMD BIOMEDICAL INC.
Model
3L-10-14003A
Catalog number
3L-10-14003A
Device description
FIA Salut Blood Glucose KPH foil packed test strip(for SS)
Published
2020-07-17
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

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
K121433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121433000GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.2013-02-14LFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260236851289PackageGS1180In Commercial Distribution
04260236850459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260236851289042602368512894260236851289
04260236850459042602368504594260236850459

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

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Primary DI, Brand, Company table
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