OP - First aid series

OP - First aid series - OP401

A device impregnated with an antimicrobial agent and intended to be applied to a surgical incision, other skin wound, or an internal structure to control bleeding, absorb fluid, and to protect against contamination. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: OVR

Device Name: Kit, First Aid, Talking

Device Class: 1

Physical State: The device looks and functions like a programmable digital audio player, playing digital audio clips as individual digital audio files containing prerecorded, spoken First Aid information in a prescribed order (and language) as user pushes specific buttons. It is nothing more than an audio player, playing First Aid information as content.

Definition: The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device works as an audio player playing various first aid instructions when buttons labeled with those first aid emergencies such as choking, burn are pressed.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The instructions are verbally relayed to the user for emergencies pertaining to CPR, Unconscious, Choking, Breathing, Allergic Reaction, Bleeding, Burns, Falls, Bone Injury, Poison, Bites, Stings, Seizures.

Regulation Number: 878.4014

Third Party Flag: N

Medical Specialty: SU

Device Id: 06974686050021

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A