Res-Cue Key WorldPoint3 blue Soft

Basic Information

• Brand Name: Res-Cue Key WorldPoint3 blue Soft
• Primary DI: 05707480134908
• Version / Model: WP-203
• Catalog Number: WP-203
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0fe063c5-04f8-4db2-8f10-1c1cfba6c967

Device Description

Rescue Key WorldPoint,3 Blue Soft

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BTM	Ventilator, emergency, manual (resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61326	Cardiopulmonary resuscitation mask, single-use	A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480122240	GS1		4	In Commercial Distribution
Package	05707480122233	GS1		100	In Commercial Distribution
Primary	05707480134908	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -18 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius