FDA UDI
In Commercial Distribution
🇺🇸 United States
DiaSpect Hemoglobin Cuvettes
DI: 04048534001540
·
Model: 90C.0001
·
DiaSpect Medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- DiaSpect Hemoglobin Cuvettes
- Primary DI
- 04048534001540
- Version / Model
- 90C.0001
- Company Name
- DiaSpect Medical GmbH
- Labeler DUNS
- 341050309
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 1
- Public Version Date
- 2022-12-28
- Public Version Status
- New
- Public Device Record Key
- 01ddda57-38cb-4ba7-b845-cb0bb94e2c6b
Device Description
For the quantitative determination of hemoglobin in 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 | 04048534001694 | GS1 | cardboard box | 5 | In Commercial Distribution | |
| Primary | 04048534001540 | GS1 | ||||
| Unit of Use | 04048534001687 | GS1 |
Customer Contacts
- Phone
- +4939203511414
- [email protected]
- Phone
- 1-800-531-5535
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)