Expression MR FlexTEMP System, Jacket

Basic Information

• Brand Name: Expression MR FlexTEMP System, Jacket
• Primary DI: 00884838033238
• Version / Model: FlexTEMP System, Jacket
• Catalog Number: 989803178181
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 8
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 50cd2c25-b0be-4ab5-92e9-41fa92de9a7a

Device Description

Disposable Flex Temp Jacket is designed for use with the FlexTEMP System, Sensor. The FlexTEMP Jacket must be used with the FlexTEMP Sensor while measuring Body temperature. This Sensor should also be used for surface temperature to reduce the occurrence of infection

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: MR Safe
• 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838033238	GS1

Customer Contacts

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