FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoPoint H2
DI: 00657498300039
·
Model: G3000-CONTCUV
·
STANBIO LABORATORY, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HemoPoint H2
- Primary DI
- 00657498300039
- Version / Model
- G3000-CONTCUV
- Catalog Number
- G3000-CONTCUV
- Company Name
- STANBIO LABORATORY, L.P.
- Labeler DUNS
- 045361136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- adad4491-0d72-4deb-b026-3f47a3acbe0a
Device Description
The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00657498300039 | GS1 |
Customer Contacts
- Phone
- 18005315535
- [email protected]