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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53303 | Glucose IVD, kit, electrometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20894046001879 | GS1 | BMB002-35-C | 400 | In Commercial Distribution | |
| Package | 30894046001876 | GS1 | BMB002-35-I | 20 | In Commercial Distribution | |
| Primary | 00894046001875 | GS1 | ||||
| Unit of Use | 40894046001873 | GS1 |
Customer Contacts
- Phone
- 1-866-373-2824
- [email protected]
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