FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy Step Blood Glucose Test Strips 50ct
DI: 00891237001195
·
Model: T5D2-00
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
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Basic Information
- Brand Name
- Easy Step Blood Glucose Test Strips 50ct
- Primary DI
- 00891237001195
- Version / Model
- T5D2-00
- Catalog Number
- 1195
- Company Name
- HOME AIDE DIAGNOSTICS, INC.
- Labeler DUNS
- 783518983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-05-03
- Public Version
- 5
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 54af7c3b-fb14-42de-8576-0267df64ca0a
Device Description
50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system
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 |
|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| 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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00891237001195 | GS1 | ||||
| Unit of Use | 20891237001199 | GS1 | ||||
| Package | 30891237001196 | GS1 | Inner Case | 280 | In Commercial Distribution | |
| Package | 50891237001190 | GS1 | Outer Case | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-915-0116
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090629 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature between 46-86 oF (8-30 oC)