Expression MR Cuff, Disp, NEO, MRI Size #3

Basic Information

• Brand Name: Expression MR Cuff, Disp, NEO, MRI Size #3
• Primary DI: 10884838053790
• Version / Model: Cuff, Disp, NEO, MRI Size #3
• Catalog Number: 989803170401
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-10-02
• Public Version: 6
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 255c89a7-d3e4-40fc-a2b1-b6db7a654fcb
• Distribution End Date: 2021-12-31

Device Description

CUFF,DISP,NEO,MRI SIZE#3

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34978	Blood pressure cuff, reusable	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884838053790	GS1
Unit of Use	00884838053793	GS1

Customer Contacts

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