Device
GL GoodLife 001 Glucose Control Solution(L1+L2 / BOX)
Manufacturer
HMD BIOMEDICAL INC.
HMD BIOMEDICAL INC.
Model: 3C-01-250037
Catalog: 3C-01-250037
DI: 04711200724844
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
GL GoodLife 001 Glucose Control Solution(L1+L2 / BOX)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a03c5ee1-b1eb-4dc3-b59e-007a0cfef1a9
Distribution Status:
In Commercial Distribution
DUNS Number:
658644174
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
04711200724875
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
600
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
04711200724844
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
04711200724844
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
NBW
System, Test, Blood Glucose, Over The Counter
Premarket Submissions
Submission Number:
K182428
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
26
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
30
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
10
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
90
Item #3 - Storage Handling Type:
Handling Environment Humidity
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
10
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
90
Item #4 - Storage Handling Type:
Storage Environment Humidity