FDA UDI In Commercial Distribution 🇺🇸 United States

Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count

DI: 00894046001875 · Model: BMB002-35 · DIABETIC SUPPLY OF SUNCOAST, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
35

Basic Information

Brand Name
Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count
Primary DI
00894046001875
Version / Model
BMB002-35
Catalog Number
BMB002-35
Company Name
DIABETIC SUPPLY OF SUNCOAST, INC.
Labeler DUNS
043081723
Distribution Status
In Commercial Distribution
Device Count in Pkg
35
Record Status
Published
Publish Date
2016-08-19
Public Version
5
Public Version Date
2020-11-25
Public Version Status
Update
Public Device Record Key
3961b638-8a66-48f3-818a-97ed7553a3da

Device Description

Advocate Redi-Code+ Test Strips for accurate monitoring of blood glucose levels 35 Count

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NBW System, Test, Blood Glucose, Over The Counter

GMDN Terms

Code Name
53303 Glucose IVD, kit, electrometry

Identifiers

Type ID
Package 20894046001879
Package 30894046001876
Primary 00894046001875
Unit of Use 40894046001873

Customer Contacts

Storage Conditions

Type
Storage Environment Atmospheric Pressure
Temperature Range
0 – 85 Percent (%) Relative Humidity
Type
Handling Environment Atmospheric Pressure
Temperature Range
0 – 85 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
39.2 – 104 Degrees Fahrenheit
Type
Storage Environment Temperature
Temperature Range
4 – 40 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
50 – 104 Degrees Fahrenheit
Type
Handling Environment Temperature
Temperature Range
10 – 40 Degrees Celsius