FDA UDI
In Commercial Distribution
🇺🇸 United States
Stratus® CS Acute Care™ MYO DilPak
DI: 00842768004629
·
Model: 10445081
·
Siemens Healthcare Diagnostics Inc.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Stratus® CS Acute Care™ MYO DilPak
- Primary DI
- 00842768004629
- Version / Model
- 10445081
- Catalog Number
- CMYO-D
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-19
- Public Version Status
- Update
- Public Device Record Key
- 2690e15a-6e0f-484c-bc52-1041fd991472
Device Description
The Stratus® CS Acute Care(TM) Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) MYO TestPak for the measurement of samples with elevated levels of Myoglobin.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | Clinical Chemistry | 862.1215 | 2 |
| MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | Clinical Chemistry | 862.1215 | 2 |
| DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5680 | 2 |
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61390 | Myoglobin IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768004629 | GS1 | ||||
| Unit of Use | 00630414009940 | GS1 |
Customer Contacts
- Phone
- +1(800)405-6473
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051650 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius