N/A IUP-075

GUDID H671IUP0751

Intrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Catheter / Transducer, 78" Lumen, with 20cc Syringe

UTAH MEDICAL PRODUCTS, INC.

Intrapartum pressure monitoring catheter

• Primary Device ID: H671IUP0751
• NIH Device Record Key: afeb250a-651d-429a-b95b-84c80ac5d840
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: IUP-075
• 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 Dimensions

• Length: 78 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671IUP0750 [Primary]
HIBCC	H671IUP0751 [Package]; Contains: H671IUP0750; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862873

FDA Product Code

• KXO: Monitor, Pressure, Intrauterine

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 [N/A]

• H671IUP0751: Intrauterine Pressure Monitoring Kit with Amnio Port / Lumen, Dual-Lumen Fluid-Filled Catheter /
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• H671ESU3052: Disposable Electrosurgical Hand Control Pencil, Two Button Handswitch, with 10' Cord
• H671DLPX102: Electrosurgical Extender Electrode, 11mm Shaft Length
• H671DLPU112: Utah MICRO Needle, Electrosurgical Needle Electrode, 0.2mm Diameter X 15mm Needle Length, 11cm S
• H671DLPU052: Utah MICRO Needle, Electrosurgical Needle Electrode, 0.2mm Diameter X 5mm Needle Length, 5.5cm S
• H671DLPT052: Electrosurgical Loop Electrode, 5mm Wide X 5mm Deep, Round Loop, 5.5cm Shaft Length
• H671DLPSQ32: Electrosurgical Loop Electrode, 10mm Wide X 4mm Deep, Square Loop, 5.5cm Shaft Length, with 15 D
• H671DLPSQ22: Electrosurgical Loop Electrode, 10mm Wide X 4mm Deep, Square Loop, 11cm Shaft Length, with 15 De
• H671DLPS052: Electrosurgical Loop Electrode, 10mm Wide X 10mm Deep, 5.5cm Shaft Length
• H671DLPN112: Utah MACRO Needle, Electrosurgical Needle Electrode, 0.8mm Diameter X 15mm Needle Length, 11cm S
• H671DLPN052: Utah MACRO Needle, Electrosurgical Needle Electrode, 0.8mm Diameter X 5mm Needle Length, 5.5cm S
• H671DLPM052: Electrosurgical Loop Electrode, 15mm Wide X 12mm Deep, 5.5cm Shaft Length
• H671DLPB052: Electrosurgical Loop Electrode, 25mm Wide X 8mm Deep, 5.5cm Shaft Length
• H671ABC1051: Arterial Blood Collection (ABC) System, Vacuum Collection Sampling System with Protected Cannula
• H671ABC0481: Arterial Blood Collection System Stand Alone, to be used with a Disposable Pressure Transducer
• H6719026421: Arterial Blood Collection Syringe
• H6719026381: Disposable Stopcock, One-Way
• H6719026371: IV Set-up Line
• H6719026351: Arterial Blood Collection Kit, 48", 6cc, w/o DPT
• H6719026321: Cannula with 1-Way Stopcock and Cap
• H6719026271: Arterial Blood Collection Kit w/o Transducer
• H6716004001: UNIVERSAL CAPS, MALE / FEMALE. NON-VENTED, 2-PACK
• H6716001221: FLUID ADMINISTRATION SET, 60", MACRO DRIP TRIFURCATED
• H6716001021: FLUID ADMINISTRATION SET, 60", MACRO
• H6716001011: FLUID ADMINISTRATION SET, 60", MICRO
• H6714003511: DISPOSABLE STOPCOCK, THREE-WAY LUER LOCK, BLUE, STERILE
• H6713100841: ARTERIAL PRESSURE MONITORING LINE, M/M, 84" STERILE TUBING
• H6713100721: ARTERIAL PRESSURE MONITORING LINE, M/M, 72" STERILE TUBING
• H6713100601: ARTERIAL PRESSURE MONITORING LINE, M/M, 60" STERILE TUBING
• H6713100481: ARTERIAL PRESSURE MONITORING LINE, M/M, 48" STERILE TUBING
• H6713100361: ARTERIAL PRESSURE MONITORING LINE, M/M, 36" STERILE TUBING
• H6713100241: ARTERIAL PRESSURE MONITORING LINE, M/M, 24" STERILE TUBING
• H6713100181: ARTERIAL PRESSURE MONITORING LINE, M/M, 18" STERILE TUBING
• H6713100121: ARTERIAL PRESSURE MONITORING LINE, M/M, 12" STERILE TUBING
• H6713100061: ARTERIAL PRESSURE MONITORING LINE, M/M, 6" STERILE TUBING
• H6713000841: ARTERIAL PRESSURE MONITORING LINE, M/F, 84" STERILE TUBING
• H6713000721: ARTERIAL PRESSURE MONITORING LINE, M/F, 72" STERILE TUBING
• H6713000601: ARTERIAL PRESSURE MONITORING LINE, M/F, 60" STERILE TUBING
• H6713000481: ARTERIAL PRESSURE MONITORING LINE, M/F, 48" STERILE TUBING
• H6713000361: ARTERIAL PRESSURE MONITORING LINE, M/F, 36" STERILE TUBING
• H6713000241: ARTERIAL PRESSURE MONITORING LINE, M/F, 24" STERILE TUBING
• H6713000181: ARTERIAL PRESSURE MONITORING LINE, M/F, 18" STERILE TUBING
• H6713000121: ARTERIAL PRESSURE MONITORING LINE, M/F, 12" STERILE TUBING
• H6713000061: ARTERIAL PRESSURE MONITORING LINE, M/F, 6" STERILE TUBING