FDA UDI
In Commercial Distribution
🇺🇸 United States
US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each
DI: 04251204325789
·
Model: 1852132
·
Bruker Daltonik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each
- Primary DI
- 04251204325789
- Version / Model
- 1852132
- Catalog Number
- 1852132
- Company Name
- Bruker Daltonik GmbH
- Labeler DUNS
- 318387958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-01-31
- Public Version
- 3
- Public Version Date
- 2018-10-05
- Public Version Status
- Update
- Public Device Record Key
- ce987143-d0e0-4372-a0b4-c0708ae792df
Device Description
HCCA Matrix 10 Tubes
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
- Yes
- 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 |
|---|---|---|---|---|
| PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | Microbiology | 866.3361 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61954 | Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs for the preparation or processing of a clinical specimen for subsequent liquid chromatography and/or mass spectrometry (LC/MS) separation and/or analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251204325789 | GS1 | ||||
| Unit of Use | 04251204325864 | GS1 |
Customer Contacts
- Phone
- +1(877)442-2231
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Max 8hr working time unrefridgerated.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Min stability 2 years.