Ambu® SPUR® II Pediatric Resuscitator

Basic Information

• Brand Name: Ambu® SPUR® II Pediatric Resuscitator
• Primary DI: 05707480150434
• Version / Model: 530614800
• Catalog Number: 530614800
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-28
• Public Version: 3
• Public Version Date: 2026-01-30
• Public Version Status: Update
• Public Device Record Key: d70e461e-501a-464f-823e-0eb27a446344

Device Description

w/CO2 Detector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEV	Cardiopulmonary resuscitation aid kit	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35693	Cardiopulmonary resuscitation kit, single-use	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480150441	GS1		6	In Commercial Distribution
Primary	05707480150434	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: 15 – 25 Degrees Celsius