FDA UDI
In Commercial Distribution
🇺🇸 United States
Washing Solution for Coagulation Analyzers
DI: 00842768017742
·
Model: 10446684
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Washing Solution for Coagulation Analyzers
- Primary DI
- 00842768017742
- Version / Model
- 10446684
- Catalog Number
- OWZC39
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 0334be5e-4e7e-4ce4-89b8-ee38df2c9c7c
Device Description
Washing Solution is used for cleaning the Siemens Healthcare Diagnostics coagulation analyzers
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30595 | Multiple coagulation factor IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768017742 | GS1 | ||||
| Unit of Use | 00842768020308 | GS1 |
Customer Contacts
- Phone
- +1(800)242-3233
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K924124 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius