FDA UDI
In Commercial Distribution
🇺🇸 United States
Hopkins Medical Products®
DI: 00817643020223
·
Model: 34265
·
HOPKINS UNIFORM COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hopkins Medical Products®
- Primary DI
- 00817643020223
- Version / Model
- 34265
- Catalog Number
- 34265
- Company Name
- HOPKINS UNIFORM COMPANY
- Labeler DUNS
- 003080678
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-28
- Public Version
- 1
- Public Version Date
- 2018-10-29
- Public Version Status
- New
- Public Device Record Key
- 0fd7d4b8-c7eb-41ee-9825-fe92cf8919c5
Device Description
A1CNow+ and 20-Test Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LCP | ASSAY, GLYCOSYLATED HEMOGLOBIN | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62205 | Glycated haemoglobin (HbA1c) monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) 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. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817643020223 | GS1 |
Customer Contacts
- Phone
- +1(800)835-1995
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090413 | 000 |