FDA UDI
In Commercial Distribution
🇺🇸 United States
BFT II Analyzer Dispo System
DI: 00842768012259
·
Model: 10446530
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- BFT II Analyzer Dispo System
- Primary DI
- 00842768012259
- Version / Model
- 10446530
- Catalog Number
- OVKG03
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2017-10-31
- Public Version
- 4
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 334108fd-1ec9-4bd6-925f-aa991a1dae14
Device Description
The cuvettes serve coagulation tests as a reaction vessel.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 56690 | Coagulation analyser IVD, laboratory, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection. The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768012259 | GS1 | ||||
| Unit of Use | 00842768024979 | GS1 |
Customer Contacts
- Phone
- +1(800)242-3233
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K984501 | 000 |