FDA UDI
In Commercial Distribution
🇺🇸 United States
D-Care
DI: 00370914001005
·
Model: 50001A
·
HUDSON SCIENTIFIC, LLC
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- D-Care
- Primary DI
- 00370914001005
- Version / Model
- 50001A
- Company Name
- HUDSON SCIENTIFIC, LLC
- Labeler DUNS
- 080339637
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-24
- Public Version
- 4
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 75b15c0f-4f54-42d8-b4af-e46e5e1024e4
Device Description
Glucose Monitoring Kit includes Glucose Meter, Test Strip, Lancing Device, Lancets and 7 Information Inserts.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60740 | Home-use blood glucose spot-check system | An electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20370914001009 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00370914001005 | GS1 | ||||
| Package | 10370914001002 | GS1 | Shipper | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 5172124047
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132086 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit