INFINITI™ AMBI 555500J402

GUDID 20705032100059

5F INFINITI AMBI 100CM JK 4.0

Cordis US Corp.

Angiographic catheter, single-use

• Primary Device ID: 20705032100059
• NIH Device Record Key: 95af9748-f3d9-45d4-ae1a-af22502e21c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITI™ AMBI
• Version Model Number: 555500J402
• Catalog Number: 555500J402
• Company DUNS: 118274128
• Company Name: Cordis US Corp.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705032100052 [Primary]
GS1	20705032100059 [Package]; Contains: 10705032100052; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232573

FDA Product Code

• DQO: Catheter, intravascular, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-26
• Device Publish Date: 2024-02-16

On-Brand Devices [INFINITI™ AMBI]

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• 20705032100158: 5F INFINITI AMBI 125CM TG 4.5
• 20705032100141: 6F INFINITI AMBI 100CM TG 4.5
• 20705032100134: 5F INFINITI AMBI 100CM TG 4.5
• 20705032100127: 6F INFINITI AMBI 125CM TG 4.0
• 20705032100110: 5F INFINITI AMBI 125CM TG 4.0
• 20705032100103: 6F INFINITI AMBI 100CM TG 4.0
• 20705032100097: 5F INFINITI AMBI 100CM TG 4.0
• 20705032100080: 6F INFINITI AMBI 125CM JK 4.0
• 20705032100073: 5F INFINITI AMBI 125CM JK 4.0
• 20705032100066: 6F INFINITI AMBI 100CM JK 4.0
• 20705032100059: 5F INFINITI AMBI 100CM JK 4.0
• 20705032100042: 6F INFINITI AMBI 125CM JK 3.5
• 20705032100035: 5F INFINITI AMBI 125CM JK 3.5
• 20705032100028: 6F INFINITI AMBI 100CM JK 3.5
• 20705032100011: 5F INFINITI AMBI 100CM JK 3.5