HEMO-NATE

Basic Information

• Brand Name: HEMO-NATE
• Primary DI: H67140200050
• Version / Model: Needleless Filter Set
• Catalog Number: 4020005
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 5d126450-e5bf-4910-a640-3111fe38e8d2

Device Description

NEEDLELESS FILTER SET, Syringe Infusion Set with a Microaggregate Blood Filter

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPB	Filter, Infusion Line	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35071	Blood transfusion filter	A microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H67140200051	HIBCC	Box	50	In Commercial Distribution
Primary	H67140200050	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K781815	000

Device Sizes

Type	Value	Unit	Text
Pore Size	18	Micrometer