FDA UDI
In Commercial Distribution
🇺🇸 United States
Deltex Medical CardioQ EDM
DI: 05055679404319
·
Model: 9051-7057
·
DELTEX MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Deltex Medical CardioQ EDM
- Primary DI
- 05055679404319
- Version / Model
- 9051-7057
- Company Name
- DELTEX MEDICAL LIMITED
- Labeler DUNS
- 225232610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c4c9bc8b-e902-499b-ac12-411b309da2ca
Device Description
The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provide clinicians with real-time information about left-ventricular blood flow.
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
- Yes
- 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 |
|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61566 | Transoesophageal vascular ultrasound monitor | A mains electricity (AC-powered) device intended to be used for monitoring cardiac output and/or fluid status through connection to a dedicated probe, which is placed in the oesophagus to measure blood flow in the descending aorta. It is based on measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle) and is displayed on the monitor as a velocity/time waveform. It is typically used during a surgical procedure or in intensive care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055679404319 | GS1 | ||||
| Package | 5055679406108 | GS1 | Cardboard Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +4401243774837
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111542 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius