AccessGUDID - DEVICE: Reusable Temperature Probe (14251679601804)

GUDID

Device Identifier (DI) Information

Brand Name: Reusable Temperature Probe
Version or Model: Skin, Adult
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2107176-033
Company Name: BluePoint Medical GmbH & Co. KG

Primary DI Number: 14251679601804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 507261522 *Terms of Use

Device Description: Probe for temperature measurement systems

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 [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7491ac4e-bebc-4709-a4d6-a33a3b5d7236
Public Version Date: December 22, 2021
Public Version Number: 1
DI Record Publish Date: December 10, 2021