FDA UDI
In Commercial Distribution
🇺🇸 United States
Xprecia Stride™ Coagulation Analyzer
DI: 00630414025148
·
Model: 11065584
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xprecia Stride™ Coagulation Analyzer
- Primary DI
- 00630414025148
- Version / Model
- 11065584
- Catalog Number
- 11065584
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-01
- Public Version
- 6
- Public Version Date
- 2021-11-19
- Public Version Status
- Update
- Public Device Record Key
- e6da5bc3-47c8-4e7b-944e-4b32693fa629
Device Description
The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.
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 |
|---|---|---|---|---|
| GGN | PLASMA, COAGULATION CONTROL | Hematology | 864.5425 | 2 |
| GJS | TEST, TIME, PROTHROMBIN | Hematology | 864.7750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62542 | Coagulation analyser IVD, point-of-care, battery-powered | An exclusively battery-powered instrument intended to be used exclusively at the point-of-care by medical professionals 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 whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. It may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry 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 | 00630414025148 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151964 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius