FDA.reportPublic FDA data

Pip

Primary DI
00732671009418
Brand
Pip
Company
AMITY HOLDINGS, LLC
Model
941
Catalog number
941
Device description
Blood Glucose Test Strips
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113208000
K213887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113208000GAL-1A BLOOD GLUCOSE MONITORING SYSTEMApex BioTechnology Corp.2012-01-26CGA
K213887000GAL-1A Plus Blood Glucose Monitoring SystemApex BioTechnology Corp.2022-03-29NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10732671109412PackageGS150In Commercial Distribution
20732671209416PackageGS11In Commercial Distribution
30732671309410PackageGS1300In Commercial Distribution
00732671009418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073267110941210732671109412
2073267120941620732671209416
3073267130941030732671309410
00732671009418007326710094187326710094180732671009418

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
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016069284
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732671109422Pip 942-2942-22021-06-21
10732671209426Pip9429422021-06-21
30732671309403Pip940-50940-502026-04-16
00732671009401Pip9409402021-06-21
00732671009425Pip 942-1942-12021-06-21
10732671109023Pip9029022020-08-27
10732671109030PIP9039032020-08-27
00732671009319PIP9319312019-12-30
00732671009326PIP9329322019-12-30
10732671105315LiteTouch5312016-09-01
10732671105322LiteTouch5322016-09-01
10732671105339LiteTouch5332016-09-01
10732671105346LiteTouch5342016-09-01
10732671105353LiteTouch5352016-09-01
10732671106176LiteTouch6172016-09-01
10732671106183LiteTouch6182016-09-01
00732671021182LiteTouch211821182021-12-21
00732671022110LiteTouch 221122112021-06-21
00732671022127LiteTouch221222122021-06-21
00732671022134LiteTouch 221322132021-06-21

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
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
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
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
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., LtdCGA2020-09-11