EKM INFLATION DEVICE 194101

GUDID 20886333207620

EKM INFLATION DEVICE

ARGON MEDICAL DEVICES, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 20886333207620
• NIH Device Record Key: bb308c85-0f5b-45d4-ad98-e002a6a0ae01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EKM INFLATION DEVICE
• Version Model Number: 194101
• Catalog Number: 194101
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333207626 [Primary]
GS1	20886333207620 [Package]; Contains: 00886333207626; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953522

FDA Product Code

• MAV: Syringe, Balloon Inflation

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: 2020-05-06
• Device Publish Date: 2016-09-21

On-Brand Devices [EKM INFLATION DEVICE]

• 20886333207620: EKM INFLATION DEVICE
• 20886333207613: EKM INFLATION DEVICE