Apollo Balloon Dilatation Catheter 802-3215U

GUDID 06958481413298

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06958481413298
• NIH Device Record Key: 20b83548-5a03-46f1-9196-5dac52d1f4a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 802-3215U
• Company DUNS: 421318800
• Company Name: BrosMed Medical Co.,Ltd.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958481413298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133852

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: 2016-09-10

On-Brand Devices [Apollo Balloon Dilatation Catheter]

• 06958481454550: rev 02
• 06958481454543: rev 02
• 06958481454536: rev 02
• 06958481454529: rev 02
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• 06958481454321: rev 02
• 06958481454314: rev 02
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• 06958481454093: rev 02
• 06958481454086: rev 02
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• 06958481454062: rev 02