AccessGUDID - DEVICE: Temperature Probes (20884838001033)

GUDID

Device Identifier (DI) Information

Brand Name: Temperature Probes
Version or Model: Skin Surface Temperature Probe
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21091A
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838001033
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Skin Surface Temperature Probe Disposable; size = 1" (25cm); probe length = 28" (71cm); sterile; minimum shelf life = 12 months; 1 cs = 20 probes; wgt = 1 lb (454g)

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -35 and 65 Degrees Celsius
Storage Environment Temperature: between -31 and 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 450f65fe-60e9-47b7-a691-8cbf7453bc3b
Public Version Date: December 08, 2023
Public Version Number: 9
DI Record Publish Date: December 05, 2016