FDA.reportPublic FDA data

Diska Nulife

Primary DI
00810115891703
Brand
Diska Nulife
Company
Diska LLC
Model
DNL-TTS01
Device description
Blood Glucose Test Strips
Published
2023-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K223722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223722000MIO Blood Glucose Monitoring SystemMio Labs, Inc.2023-06-28NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810115891703PackageGS1200In Commercial Distribution
00810115891697PrimaryGS10
00810115891680Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810115891703008101158917038101158917030810115891703
00810115891697008101158916978101158916970810115891697
00810115891680008101158916808101158916800810115891680

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-675-6037ashish.bharal@diskatech.com

Regulatory Flags#

DUNS number
006311259
Device count
50
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
00810115891581Diska NulifeDNL-TMB-2282-G2023-08-25
00810115891697Diska NulifeDNL-TTS012023-08-25
00810115892328Diska NulifeDNL-TMB2084-A2023-10-20
00810115892342Diska NuLifeVGM04(Ref. DNL-VGM04)2023-10-05
00810115892427Diska NuLifeVGS01 (REF: DNL-VGS01)2023-10-05
00810115892335Diska NulifeDNL-TMB2084-A2023-10-20
00810115892366Diska NuLifeDNL-GBS-2012-B2023-10-05
00810115892380Diska NuLifeDNL-YM4022023-10-05
00810115892458Diska NuLifeDNL-VGC012023-10-05
00810115892359Diska NuLifeVGM04(Ref. DNL-VGM04)2023-10-05
00810115892373Diska NuLifeDNL-GBS-2012-B2023-10-05
00810115892403Diska NuLifeDNL-YM4022023-10-05
00810115892441Diska NuLifeVGS01 (REF: DNL-VGS01)2023-10-05
00810115892465Diska NuLifeDNL-VGC012023-10-05
00810115891642Diska NulifeHH-XIII-T2023-08-25
00810115891666Diska NulifeTCS012023-08-25
00810115891710Diska NulifeI2023-08-25
00810115891598Diska NulifeDNL-TMB-2282-G2023-08-25
00810115891659Diska NulifeHH-XIII-T2023-08-25
00810115891673Diska NulifeTCS012023-08-25

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