NICE1 Hand/Wrist, Universal, S/M

Organization name

Nice Recovery Systems LLC

SRN

US-MF-000018331

Manufacturer status

Active

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

• CW010

  Caution: Consult Accompanying Documents
• CW007

  Do not use if package is damaged and consult instructions for use.
• CW018

  Refer to User Manual
• CW262

  Disposable therapy wraps are designed for single patient use only and may only be used on the same patient for the length of the treatment.
• 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.
• CW999

  For adult use only, the use of NICE1 by children or incapacitated persons may be dangerous.
• CW999

  Do not use over sensitive skin areas or in the presence of poor circulation.
• CW999

  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.
• CW999

  Dressings used under the therapy wrap should be applied lightly. Do not use pins to secure the therapy wraps or hoses.
• CW999

  Do not apply the therapy wrap so tightly as to restrict blood or fluid flow.
• CW999

  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).
• CW999

  Use of this device may also cause frostbite or tissue damage if used incorrectly.
• CW999

  If unusual swelling, skin discoloration or discomfort occurs, immediately discontinue use of NICE1 and consult a healthcare professional.

Primary placement in France; available across 10 countries total.

Trade name

NICE1 Hand/Wrist, Universal, S/M

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00850014566111

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0850014566401807K

Reference / catalog number

40180

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://getnice.com/pages/quick-start-guide

Clinical sizes

No clinical sizes registered for this device.

• 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.