AccessGUDID - DEVICE: AirLife™ (10889483587904)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife™
Version or Model: 6600-0208-700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6600-0208-700
Company Name: AirLife Finland Oy

Primary DI Number: 10889483587904
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368457563 *Terms of Use
Previous DI: 10190752181205

Device Description: AirLife™ Infant Skin Temperature Probe, Single Patient Use (Lullaby™, Care Plus™)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35254	General-purpose patient temperature probe, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMT	Warmer, Infant Radiant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121625	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 95 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ddddb9e-0848-4aee-b398-3cf67c4c9df8
Public Version Date: April 03, 2025
Public Version Number: 1
DI Record Publish Date: March 26, 2025