AirLife™ 6600-0628-700

GUDID 10889483587959

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

AirLife Finland Oy

General-purpose patient temperature probe, reusable

• Primary Device ID: 10889483587959
• NIH Device Record Key: 817f6c14-8ec3-48cc-b3f8-c8b6eeb10534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife™
• Version Model Number: 6600-0628-700
• Catalog Number: 6600-0628-700
• Company DUNS: 368457563
• Company Name: AirLife Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752181236 [Previous]
GS1	10889483587959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121625

FDA Product Code

• FMT: Warmer, Infant Radiant

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

[10889483587959]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [AirLife™]

• 10889483587959: AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™)
• 20889483587901: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
• 20889483587888: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)
• 10889483577387: AirLife™ Infant Skin Temperature Probe, Reusable (Giraffe™, Panda™)
• 20889483577377: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™)
• 20889483577360: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™)