Temperature Probes

Basic Information

• Brand Name: Temperature Probes
• Primary DI: 20884838006922
• Version / Model: Foley Catheter Temperature Probe
• Catalog Number: 21097A
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-06-29
• Public Version: 6
• Public Version Date: 2023-01-18
• Public Version Status: Update
• Public Device Record Key: 68e20a60-e698-4f06-a2d5-27721784dd5b
• Distribution End Date: 2022-11-30

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

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZL	CATHETER, RETENTION TYPE, BALLOON	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20884838006922	GS1
Unit of Use	00884838006928	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -35 – 65 Degrees Celsius