FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoCue® Hb 301 Microcuvettes
DI: 17311091118018
·
Model: 111801
·
Hemocue AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- HemoCue® Hb 301 Microcuvettes
- Primary DI
- 17311091118018
- Version / Model
- 111801
- Catalog Number
- 111801
- Company Name
- Hemocue AB
- Labeler DUNS
- 356164426
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-05-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3930944f-a679-4ac1-8683-0d217ec37f08
Device Description
HemoCue Hb 301 Microcuvettes 4x50 vial
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GKR | System, Hemoglobin, Automated | Hematology | 864.5620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32435 | Haemoglobin analyser IVD, point-of-care | A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07311091118011 | GS1 | package | 4 | In Commercial Distribution | |
| Primary | 17311091118018 | GS1 | ||||
| Unit of Use | 27311091118015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK060048 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius