General Purpose Rectal/Esophageal Probe, Large

Basic Information

• Brand Name: General Purpose Rectal/Esophageal Probe, Large
• Primary DI: 04260651380197
• Version / Model: AR-275PRA
• Catalog Number: 011-00119
• Company Name: Sensatronic GmbH
• Labeler DUNS: 331950332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-10
• Public Version: 1
• Public Version Date: 2023-11-20
• Public Version Status: New
• Public Device Record Key: d8525147-0fe6-4a2b-aae1-e33dd254b550

Device Description

Reusable temperature probe, rectal/esophageal, large

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	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	04260651380197	GS1

Device Sizes

Type	Value	Unit	Text
Length	2.8	Meter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity