FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy Step Blood Glucose Monitoring System
DI: 00891237001188
·
Model: T5D4-00
·
HOME AIDE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Easy Step Blood Glucose Monitoring System
- Primary DI
- 00891237001188
- Version / Model
- T5D4-00
- Catalog Number
- 1188
- 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
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ad3fa71e-6906-42f6-8d2b-2c4cdd0f03ff
Device Description
Blood Glucose Testing Monitor to be used with Easy Step test strips Test Sample:Capillary Whole Blood from Fingertip, Palm and Forearm Sample Volume:>0.5 uL Measuring Unit:mg/dL or mmol/L Measuring Range:20 - 600 mg/dL (1.1 - 33.3 mmol/L) Test Time:5 sec Memory Capacity:300 most recent results Average:7/14/30 days average results External Output: USB data port Power supply:One 3-Volt lithium battery (CR-2032) Battery Life:Approximately 1000 tests Dimension and Weight:79 x 60 x17 mm ; 55 g
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 |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | 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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00891237001188 | GS1 | ||||
| Package | 10891237001185 | GS1 | Case | 112 | In Commercial Distribution |
Customer Contacts
- Phone
- 18009150116
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090629 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep meter within 39-86 oF (4-30 oC) and out of direct sunlight
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius