FDA UDI
In Commercial Distribution
🇺🇸 United States
Automated Blood Coagulation Analyzer CA-600 series CA-620
DI: 04987562425686
·
Model: BR142626
·
SYSMEX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Automated Blood Coagulation Analyzer CA-600 series CA-620
- Primary DI
- 04987562425686
- Version / Model
- BR142626
- Catalog Number
- BR142626
- Company Name
- SYSMEX CORPORATION
- Labeler DUNS
- 690664461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-04
- Public Version
- 5
- Public Version Date
- 2025-09-19
- Public Version Status
- Update
- Public Device Record Key
- bff5d6d6-6c1e-40b6-ab4e-085f7a35df51
Device Description
Automated Blood Coagulation Analyzer CA-620
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | Hematology | 864.5425 | 2 |
| GKP | INSTRUMENT, COAGULATION, AUTOMATED | Hematology | 864.5400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56689 | Coagulation analyser IVD, laboratory | An electrically-powered automated or semi-automated 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987562425686 | GS1 |
Customer Contacts
- Phone
- +1(888)879-7639
- [email protected]