FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoCue® Glucose 201 DM Analyzer
DI: 07311091214447
·
Model: 121444
·
Hemocue AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HemoCue® Glucose 201 DM Analyzer
- Primary DI
- 07311091214447
- Version / Model
- 121444
- Catalog Number
- 121444
- Company Name
- Hemocue AB
- Labeler DUNS
- 356164426
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-31
- Public Version
- 4
- Public Version Date
- 2022-10-31
- Public Version Status
- Update
- Public Device Record Key
- 7756ebf1-3af7-40f9-9940-a68b04599ab7
Device Description
HemoCue Glucose 201 DM Analyzer mmol/L plasma
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62538 | Glucose monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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 | 07311091214447 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041230 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage in <90 % non-condensing humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius