GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE

Basic Information

• Brand Name: GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE
• Primary DI: 00195278358363
• Version / Model: NA
• Company Name: DATEX-OHMEDA INC
• Labeler DUNS: 080887689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-10
• Public Version: 1
• Public Version Date: 2021-11-18
• Public Version Status: New
• Public Device Record Key: f357c676-97a1-448a-bc21-c0a045d77595

Device Description

GIRAFFE PANDA DISPOSABLE INFANT SKIN TEMPERATUR PROBE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
FMZ	INCUBATOR, NEONATAL	General Hospital	880.5400	2
FMT	WARMER, INFANT RADIANT	General Hospital	880.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278358363	GS1

Premarket Submissions

Submission Number	Supplement Number
K123309	000
K152809	000
K152814	000
K201628	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius