FDA UDI
In Commercial Distribution
🇺🇸 United States
Quantra QPlus System
DI: 10850003761043
·
Model: KT-0012
·
HEMOSONICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Quantra QPlus System
- Primary DI
- 10850003761043
- Version / Model
- KT-0012
- Company Name
- HEMOSONICS, LLC
- Labeler DUNS
- 193921041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-09-28
- Public Version
- 1
- Public Version Date
- 2020-10-06
- Public Version Status
- New
- Public Device Record Key
- bac07a52-1b4e-45d4-9a95-b787faafe5ae
Device Description
Quantra Cleaning Cartridge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QFR | Coagulation system for the measurement of whole blood viscoelastic properties | Hematology | 864.5430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62540 | Coagulation analyser IVD, point-of-care, line-powered | A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, 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 include 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00850003761046 | GS1 | ||||
| Primary | 10850003761043 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN180017 | 000 |