Axiom® PVC

GUDID M6655000403

Thoracic Catheter, Straight, PVC

AXIOM MEDICAL, INCORPORATED

Pleural catheter

• Primary Device ID: M6655000403
• NIH Device Record Key: eac0f86f-2988-4f67-8698-4efce36d2fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom® PVC
• Version Model Number: 500040
• Company DUNS: 094439676
• Company Name: AXIOM MEDICAL, INCORPORATED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com
• Phone: 310-533-9020
• Email: Sales@AxiomMed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M6655000400 [Primary]
HIBCC	M6655000401 [Package]; Contains: M6655000400; Package: Box [10 Units]; In Commercial Distribution
HIBCC	M6655000403 [Package]; Contains: M6655000401; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K841593

FDA Product Code

• GBS: Catheter, Ventricular, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-03
• Device Publish Date: 2018-09-23

On-Brand Devices [Axiom® PVC]

• M6655222363: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222323: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222283: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222243: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222203: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222163: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222123: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222103: Thoracic Catheter, Straight, PVC, With Trocar
• M6655222083: Thoracic Catheter, Right Angle PVC
• M6655111403: Thoracic Catheter, Right Angle PVC
• M6655111363: Thoracic Catheter, Right Angle PVC
• M6655111323: Thoracic Catheter, Right Angle PVC
• M6655111283: Thoracic Catheter, Right Angle PVC
• M6655111243: Thoracic Catheter, Right Angle PVC
• M6655111203: Thoracic Catheter, Right Angle PVC
• M6655110163: Thoracic Catheter, Right Angle PVC
• M6655000403: Thoracic Catheter, Straight, PVC
• M6655000363: Thoracic Catheter, Straight, PVC
• M6655000323: Thoracic Catheter, Straight, PVC
• M6655000283: Thoracic Catheter, Straight, PVC
• M6655000243: Thoracic Catheter, Straight, PVC
• M6655000203: Thoracic Catheter, Straight, PVC
• M6655000163: Thoracic Catheter, Straight, PVC
• M6655000143: Thoracic Catheter, Straight, PVC