FDA UDI
In Commercial Distribution
🇺🇸 United States
seca mVSA 535
DI: 04012030019545
·
Model: 535
·
seca GmbH & Co. KG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- seca mVSA 535
- Primary DI
- 04012030019545
- Version / Model
- 535
- Catalog Number
- 5351220131
- Company Name
- seca GmbH & Co. KG
- Labeler DUNS
- 316584937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-28
- Public Version
- 4
- Public Version Date
- 2020-10-12
- Public Version Status
- Update
- Public Device Record Key
- de237bca-af9e-43a3-ab93-7a665075931b
Device Description
Spot-check-monitor inclusive blood pressure, Masimo Spo2 and FILAC temperature module.
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 |
|---|---|---|---|---|
| DXN | System, measurement, blood-pressure, non-invasive | Cardiovascular | 870.1130 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| FLL | Thermometer, electronic, clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57960 | Multiple physiological parameter spot-check system, clinical | An electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04012030019545 | GS1 |
Customer Contacts
- Phone
- +1(800)5427322
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192092 | 000 |