AirLife™

Basic Information

• Brand Name: AirLife™
• Primary DI: 10889483587959
• Version / Model: 6600-0628-700
• Catalog Number: 6600-0628-700
• Company Name: AirLife Finland Oy
• Labeler DUNS: 368457563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-26
• Public Version: 2
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: 817f6c14-8ec3-48cc-b3f8-c8b6eeb10534

Device Description

AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™)

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMT	Warmer, Infant Radiant	General Hospital	880.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37340	General-purpose patient temperature probe, reusable	A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889483587959	GS1
Previous	10190752181236	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius