NICE1

Organization name

Nice Recovery Systems LLC

SRN

US-MF-000018331

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Caution: Consult Accompanying Documents
• CW018

  Refer to User Manual
• CW007

  Do not use if package is damaged and consult instructions for use.
• CW262

  Single Patient multiple use
• CW020

  Do not attempt to sterilize this device by any means.
• CW999

  The therapy wrap should be periodically cleaned if it is used on the same patient for an extended period. Soiled wraps should be replaced and discarded. For adult use only, the use of NICE1 by children or incapacitated persons may be dangerous. Do not use over sensitive skin areas or in the presence of poor circulation. Therapy wraps are non-sterile and should NEVER be directly applied to skin including any open wound or breached skin. Wrap should NEVER be enclosed in a bandage to prevent moisture build up. Dressings used under the therapy wrap should be applied lightly. Do not use pins to secure the therapy wraps or hoses. Do not apply the therapy wrap so tightly as to restrict blood or fluid flow. If unusual swelling, skin discoloration or discomfort occurs, immediately discontinue use of NICE1 and consult a healthcare professional. Use of this device may also cause frostbite or tissue damage if used incorrectly. Do not allow the therapy wrap or hoses to contact sharp objects that could puncture it.
• CW999

  • NICE1 or any cold therapy device should not be used by patients that: ◦ have significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis, or ischemia). ◦ have acute paroxysmal cold hemoglobinuria or cryoglobulinemia.have Raynaud’s disease or cold hypersensitivity (cold urticarial).

Primary placement in France; available across 10 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES
• Z120607PNEUMATIC COMPRESSION EQUIPMENT

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.