Chocolate XD PTCA Balloon Catheter NHC CD141402515RX

GUDID M874CD141402515RX1

Chocolate XD PTCA Balloon Catheter NHC

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic

• Primary Device ID: M874CD141402515RX1
• NIH Device Record Key: b6a87c7c-e4eb-4951-9e56-21f25b95f0a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chocolate XD PTCA Balloon Catheter NHC
• Version Model Number: A
• Catalog Number: CD141402515RX
• Company DUNS: 623861577
• Company Name: TRIREME MEDICAL, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M874CD141402515RX1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153682

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

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: 2019-10-07
• Device Publish Date: 2018-02-05

On-Brand Devices [Chocolate XD PTCA Balloon Catheter NHC]

• M874CD141403520RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141403515RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141403510RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141403020RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141403015RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141403010RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141402520RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141402515RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141402510RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141402020RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141402015RX1: Chocolate XD PTCA Balloon Catheter NHC
• M874CD141402010RX1: Chocolate XD PTCA Balloon Catheter NHC