AccessGUDID - DEVICE: General Purpose Rectal/Esophageal Probe, Large, Schiller (04260651380265)

GUDID

Device Identifier (DI) Information

Brand Name: General Purpose Rectal/Esophageal Probe, Large, Schiller
Version or Model: AR-300S1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2.101093
Company Name: Sensatronic GmbH

Primary DI Number: 04260651380265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 331950332 *Terms of Use

Device Description: Reusable temperature probe, rectal/esophageal, large, Schiller AG branded

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203643	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 -30 and 70 Degrees Celsius
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 3.0 Meter

Device Record Status

Public Device Record Key: bc557747-e2d5-4a12-a603-ad97835bad7c
Public Version Date: February 10, 2025
Public Version Number: 2
DI Record Publish Date: December 01, 2021