8001 Series Foley Catheter Temperature Probe

Basic Information

• Brand Name: 8001 Series Foley Catheter Temperature Probe
• Primary DI: H29780010634140
• Version / Model: 8001-063-414
• Catalog Number: 8001-063-414
• Company Name: MEASUREMENT SPECIALTIES, INC.
• Labeler DUNS: 029351079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 3
• Public Version Date: 2018-09-18
• Public Version Status: Update
• Public Device Record Key: 2bb85a38-48dd-4afe-9874-056a308e961d

Device Description

8001 Series Foley Catheter Temperature Probe, 14 FR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Package	H29780010634142	HIBCC	Outer Box	10	In Commercial Distribution
Package	H29780010634141	HIBCC	Inner Box	10	In Commercial Distribution
Primary	H29780010634140	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	14	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 55 Degrees Celsius