FDA UDI
In Commercial Distribution
🇺🇸 United States
ReliOn
DI: 00021292009274
·
Model: ReliOn ALL-IN-ONE Compact Blood Glucose Testing System
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ReliOn
- Primary DI
- 00021292009274
- Version / Model
- ReliOn ALL-IN-ONE Compact Blood Glucose Testing System
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- e342a76f-d891-4b88-80b4-5d2467a4ff4d
Device Description
ReliOn ALL-IN-ONE Compact Blood Glucose Testing System 50 Test Strips With Built-In Meter
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 30854 | Home-use/point-of-care blood glucose monitoring system IVD | A 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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10681131130315 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00681131130318 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00021292009274 | GS1 |
Customer Contacts
- Phone
- 479-204-8686
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051147 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit