DELTRAN

Basic Information

• Brand Name: DELTRAN
• Primary DI: H6719020900
• Version / Model: Custom
• Catalog Number: 902-090
• 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: 4
• Public Version Date: 2019-12-18
• Public Version Status: Update
• Public Device Record Key: a1ae3110-9bca-49b7-9618-f15d738079b2

Device Description

DELTRAN II, Disposable Pressure Transducer System, Neonatal 30cc/hr Flow Rate

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
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	870.2850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35511	Vascular catheter flush valve, continuous	A specialized, sterile, Y-piece device intended to be connected in an infusion line to an indwelling catheter and provide for the connection of a second infusion source. The second source usually serves to maintain a low keep vein open (KVO) flow in the catheter to prevent clotting. This device (the flush valve) may be equipped with a manually-operated mechanism to permit flushing of the line at a free-flow rate. This is a single-use device.	No	Active
45275	Invasive blood pressure transducer set	A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H6719020901	HIBCC	Box	25	In Commercial Distribution
Primary	H6719020900	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Flow Rate - 30 cc/hr