FDA.reportPublic FDA data

GL GoodLife AC11-Strip(foil)

Primary DI
00389154000709
Brand
GL GoodLife AC11-Strip(foil)
Company
HMD BIOMEDICAL INC.
Model
3L-10-16003F
Catalog number
3L-10-16003F
Device description
GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.)
Published
2017-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K113307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113307000GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.2012-07-27LFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00389154000709PackageGS1120Not in Commercial Distribution
00389154000693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00389154000709003891540007093891540007090389154000709
00389154000693003891540006933891540006930389154000693

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
1-800-555-3453sales@gl-diabetes.com

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
true
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
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563841Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563865Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06223015680010Be SureEPS BIO TECHNOLOGY CORP.NBW2026-05-07
06225000563858Be Smart Blood Glucose MeterEPS BIO TECHNOLOGY CORP.NBW2026-05-07
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
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
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28