AccessGUDID - DEVICE: Temperature Probes (20884838006922)

GUDID

Device Identifier (DI) Information

Brand Name: Temperature Probes
Version or Model: Foley Catheter Temperature Probe
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21097A
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838006922
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Foley Catheter Temperature Probe Disposable; size = 18 Fr; probe length = 17" (43cm); sterile; minimum shelf life = 12 months; 1 cs = 10 probes; wgt = 1 lb (454g)

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:	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
EZL	CATHETER, RETENTION TYPE, BALLOON

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 68e20a60-e698-4f06-a2d5-27721784dd5b
Public Version Date: January 18, 2023
Public Version Number: 6
DI Record Publish Date: June 29, 2018