FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoCue® WBC Microcuvettes
DI: 17311091130034
·
Model: 113003
·
Hemocue AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
40
Basic Information
- Brand Name
- HemoCue® WBC Microcuvettes
- Primary DI
- 17311091130034
- Version / Model
- 113003
- Catalog Number
- 113003
- Company Name
- Hemocue AB
- Labeler DUNS
- 356164426
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2016-05-31
- Public Version
- 4
- Public Version Date
- 2022-12-02
- Public Version Status
- Update
- Public Device Record Key
- 5e4f08b4-668e-4669-9c61-c5be02afa6ab
Device Description
HemoCue WBC Microcuvettes 4x40 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 |
|---|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | Hematology | 864.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35476 | Haematological cell analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07311091130037 | GS1 | package | 4 | In Commercial Distribution | |
| Primary | 17311091130034 | GS1 | ||||
| Unit of Use | 27311091130031 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071652 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 95 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- An unopened vial can be stored for shorter period of time (4 weeks) outside specified storage conditions down to 0°C and up to 50°C, <90% non-condensing humidity.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius