HEMO-NATE 4020009

GUDID H67140200091

FILTER, A Disposable 18 Micron Blood Filter

UTAH MEDICAL PRODUCTS, INC.

Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter Blood transfusion filter

• Primary Device ID: H67140200091
• NIH Device Record Key: 73c99ea0-0b8e-4b18-9b86-4e4ed21346c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMO-NATE
• Version Model Number: Filter
• Catalog Number: 4020009
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com
• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Dimensions

• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer
• Pore Size: 18 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H67140200090 [Primary]
HIBCC	H67140200091 [Package]; Contains: H67140200090; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K781815

FDA Product Code

• FPB: Filter, Infusion Line

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [HEMO-NATE]

• H67140200091: FILTER, A Disposable 18 Micron Blood Filter
• H67140200071: FILTER SET, Syringe Infusion Set with a Microaggregate Blood Filter
• H67140200051: NEEDLELESS FILTER SET, Syringe Infusion Set with a Microaggregate Blood Filter