NIBP CUFF

Basic Information

• Brand Name: NIBP CUFF
• Primary DI: 06944413811874
• Version / Model: 01.57.471907
• Company Name: Edan Instruments, Inc.
• Labeler DUNS: 529173163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-01
• Public Version: 1
• Public Version Date: 2021-02-09
• Public Version Status: New
• Public Device Record Key: 7c26223e-ff45-455e-b67f-7dda60b7ff94

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXQ	Blood Pressure Cuff	Cardiovascular	870.1120	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	06944413811874	GS1

Premarket Submissions

Submission Number	Supplement Number
K202892	000