DIALY-NATE 4000557

GUDID H67140005570

SET, SINGLE USE / LOW VOLUME, Peritoneal Dialysis Set for Neonates

UTAH MEDICAL PRODUCTS, INC.

Peritoneal dialysis system tubing set

• Primary Device ID: H67140005570
• NIH Device Record Key: 8cf735c0-fb86-4efe-85f5-361e3305105d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIALY-NATE
• Version Model Number: Set
• Catalog Number: 4000557
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H67140005570 [Primary]

FDA Product Code

• FKO: Catheter, Peritoneal Dialysis, Single Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [DIALY-NATE]

• H67140005670: SET WITH LUER CONNECTORS AND A 4-WAY STOPCOCK, Peritoneal Dialysis Set for Neonates
• H67140005570: SET, SINGLE USE / LOW VOLUME, Peritoneal Dialysis Set for Neonates
• H67140005470: SET W/ ADDITIONAL BURETTE ASSEMBLY, Peritoneal Dialysis Set for Neonates
• H67140005370: SET W/ LUER LOCKING CONNECTIONS, W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neo
• H67140005270: SET W/ LUER LOCKING CONNECTIONS AND HEATING COIL, Peritoneal Dialysis Set for Neonates
• H67140005170: SET W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates
• H67140005070: SET, Peritoneal Dialysis Set for Neonates