CritiCool Pro
- Primary DI
- 07290107580564
- Brand
- CritiCool Pro
- Company
- M.T.R.E. ADVANCED TECHNOLOGIES LTD.
- Model
- VL4500N 115VAC
- Catalog number
- 100-00213
- Device description
- Thermoregulation System combined with patient monitor
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| DWJ | System, Thermal Regulating |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290107580564 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290107580564 | 07290107580564 | 7290107580564 |
GMDN Terms
| Term | Definition |
|---|
| Single-patient intensive/general healthcare physiologic monitoring system | An assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use. |
Regulatory Flags
- DUNS number
- 532022530
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- true
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 07290102932313 | CritiCool Pro | VitaLogik4000 3/5Lead,NI Nellcor Blue | 681-0R0-013 | 2016-09-24 |
| 07290102932337 | CritiCool Pro | VitaLogik4000 3/5Lead,NI Masimo Blue | 681-0R0-023 | 2016-09-24 |
| 07290102932344 | CritiCool Pro | VitaLogik4500 3/5Lead Nellcor Blue | 681-0R0-113 | 2016-09-24 |
| 07290107580526 | CritiCool Pro | VL4000N 115VAC | 100-00013 | 2016-09-24 |
| 07290107580540 | CritiCool Pro | VL4000M 115VAC | 100-00113 | 2016-09-24 |
| 07290107580588 | CritiCool Pro | VL4500M 115VAC | 100-00313 | 2016-09-26 |
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| 07290012127182 | CureWrap™ | Infant, Up to 4Kg | 500-03518 | 2016-09-24 |
| 07290012127199 | CureWrap™ | Infant, 4-7Kg (single) | 500-03521 | 2016-09-24 |
| 07290012127205 | ThermoWrap™ | Pediatric, 79–91cm (single) | 500-03131 | 2016-09-24 |
| 07290012127212 | ThermoWrap™ | Pediatric , 91–104cm (single) | 500-03136 | 2016-09-24 |
| 07290012127229 | ThermoWrap™ | Pediatric, 104–122cm (single) | 500-03141 | 2016-09-24 |
| 07290012127236 | ThermoWrap™ | Pediatric, 122–135cm, (single) | 500-03148 | 2016-09-24 |
| 07290012127243 | Universal ThermoWrap™ | Adults, 135-152cm, (single) | 500-03153 | 2016-09-24 |
| 07290012127250 | ThermoWrap™ | Universal, Adults, 152-168cm (single) | 500-03160 | 2016-09-24 |
| 07290012127267 | ThermoWrap™ | Universal, Adults, 168-189cm, (single) | 500-03166 | 2016-09-24 |
| 07290012127274 | ThermoWrap™ | Cardiac, Adults, 165-172cm, (single) | 500-03363 | 2016-09-24 |
| 07290012127281 | ThermoWrap™ | Infant, 2.5–4.0Kg,(single) | 500-03118 | 2016-09-24 |
| 07290012127298 | ThermoWrap™ | Infant, 4.0–7.0Kg, (single) | 500-03121 | 2016-09-24 |
| 07290012127304 | ThermoWrap™ | Infant, 7.0–11Kg, (single) | 500-03125 | 2016-09-24 |
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