FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy Plus II Control Solution - LOW
DI: 00891237001676
·
Model: GOD11
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Easy Plus II Control Solution - LOW
- Primary DI
- 00891237001676
- Version / Model
- GOD11
- Catalog Number
- 1676
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-01
- Public Version
- 3
- Public Version Date
- 2018-06-14
- Public Version Status
- Update
- Public Device Record Key
- 9329bf9a-a50f-4b68-8b1c-d870cbc04784
Device Description
Blood glucose control solution for use with Easy Plus II blood glucose testing system
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 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00891237001676 | GS1 | ||||
| Package | 10891237001673 | GS1 | Inner Case | 100 | In Commercial Distribution | |
| Package | 20891237001670 | GS1 | Outer Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-915-0116
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at temperatures between 46-86oF (8-30oC).