FDA UDI
In Commercial Distribution
🇺🇸 United States
ROTEM®
DI: 04260160470587
·
Model: delta System (US/CA)
·
Tem Innovations GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ROTEM®
- Primary DI
- 04260160470587
- Version / Model
- delta System (US/CA)
- Catalog Number
- 201001
- Company Name
- Tem Innovations GmbH
- Labeler DUNS
- 506692297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-15
- Public Version
- 3
- Public Version Date
- 2020-02-03
- Public Version Status
- Update
- Public Device Record Key
- 23ee333b-eea7-480b-bc7f-1d4a5654d998
Device Description
The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
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
- 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 |
| 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 | 04260160470587 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083842 | 000 |