Smiths Medical

Basic Information

• Brand Name: Smiths Medical
• Primary DI: 10817357021100
• Version / Model: MX4710
• Company Name: HYGIA HEALTH SERVICES, INC.
• Labeler DUNS: 177939027
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2021-03-19
• Public Version Status: Update
• Public Device Record Key: 6b545ddf-4521-4bac-a10f-eaaeb6ae362f
• Distribution End Date: 2019-07-31

Device Description

Clear Cuff® 1000ml pressure infusor

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	880.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13100	Intravenous pressure infusor, manual, reusable	A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30817357021104	GS1	Box	10	Not in Commercial Distribution	2021-03-19
Primary	10817357021100	GS1