FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoPoint® H2 n•x•t Microcuvettes
DI: 00657498301654
·
Model: 3016-050
·
STANBIO LABORATORY, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
50
Basic Information
- Brand Name
- HemoPoint® H2 n•x•t Microcuvettes
- Primary DI
- 00657498301654
- Version / Model
- 3016-050
- Catalog Number
- 3016-050
- Company Name
- STANBIO LABORATORY, L.P.
- Labeler DUNS
- 045361136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2022-08-31
- Public Version Status
- Update
- Public Device Record Key
- 45835534-4852-40e6-a8c9-156b3c04d3d5
Device Description
For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
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 | 00657498000212 | GS1 | box | 4 | In Commercial Distribution | |
| Primary | 00657498301654 | GS1 | ||||
| Package | 00657498000205 | GS1 | box | 2 | In Commercial Distribution | |
| Unit of Use | 00657498301609 | GS1 | ||||
| Package | 00657498002001 | GS1 | box | 4 | Not in Commercial Distribution | 2022-08-30 |
| Package | 00657498001998 | GS1 | box | 2 | Not in Commercial Distribution | 2022-08-30 |
Customer Contacts
- Phone
- 18005315535
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius