FDA UDI
In Commercial Distribution
🇺🇸 United States
Dimension® Reaction Vessels
DI: 00842768013928
·
Model: 10445044
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dimension® Reaction Vessels
- Primary DI
- 00842768013928
- Version / Model
- 10445044
- Catalog Number
- RXV1A
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 3
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 3049c26f-f20e-4b1a-95e6-0dbe11f37c1a
Device Description
Dimension® Heterogenous Immunoassay Module - Reaction Vessels (1000) and Waste Container Liners (5)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
| JMG | Radioimmunoassay (two-site solid phase), ferritin | Immunology | 866.5340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63297 | Laboratory waste receptacle liner IVD | A device made of disposable materials intended to be placed inside a reusable waste receptacle for the collection and containment of waste, including biologically-contaminated waste products, resulting from in vitro diagnostic procedures. It creates a barrier to contamination, reduces cleaning requirements, and protects the waste receptacle from damage. It is typically made of synthetic polymer materials and should be discarded, with its waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768013928 | GS1 |
Customer Contacts
- Phone
- +1(800)441-9250
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius