FDA UDI
In Commercial Distribution
🇺🇸 United States
ROTEM®
DI: 04260160470112
·
Model: ROTROL P
·
Tem Innovations GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- ROTEM®
- Primary DI
- 04260160470112
- Version / Model
- ROTROL P
- Catalog Number
- 503-25-US, 503-25
- Company Name
- Tem Innovations GmbH
- Labeler DUNS
- 506692297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2021-08-20
- Public Version Status
- Update
- Public Device Record Key
- 851cdb67-736b-4367-ae7e-46d5c76665f3
Device Description
ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only.
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 30590 | Multiple coagulation factor IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260160470112 | GS1 | ||||
| Unit of Use | 04260160470532 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083842 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius