Apollo Balloon Dilatation Catheter 802-3715U

GUDID 06958481413397

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06958481413397
• NIH Device Record Key: 256bc92b-ea96-4983-86b6-eb0c39a9b20a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Balloon Dilatation Catheter
• Version Model Number: rev 01
• Catalog Number: 802-3715U
• 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	06958481413397 [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
• 06958481454512: rev 02
• 06958481454505: rev 02
• 06958481454499: rev 02
• 06958481454482: rev 02
• 06958481454475: rev 02
• 06958481454468: rev 02
• 06958481454451: rev 02
• 06958481454444: rev 02
• 06958481454437: rev 02
• 06958481454420: rev 02
• 06958481454413: rev 02
• 06958481454406: rev 02
• 06958481454390: rev 02
• 06958481454383: rev 02
• 06958481454376: rev 02
• 06958481454369: rev 02
• 06958481454352: rev 02
• 06958481454345: rev 02
• 06958481454338: rev 02
• 06958481454321: rev 02
• 06958481454314: rev 02
• 06958481454307: rev 02
• 06958481454291: rev 02
• 06958481454284: rev 02
• 06958481454277: rev 02
• 06958481454260: rev 02
• 06958481454253: rev 02
• 06958481454246: rev 02
• 06958481454239: rev 02
• 06958481454222: rev 02
• 06958481454215: rev 02
• 06958481454208: rev 02
• 06958481454192: rev 02
• 06958481454185: rev 02
• 06958481454178: rev 02
• 06958481454161: rev 02
• 06958481454154: rev 02
• 06958481454147: rev 02
• 06958481454130: rev 02
• 06958481454123: rev 02
• 06958481454116: rev 02
• 06958481454109: rev 02
• 06958481454093: rev 02
• 06958481454086: rev 02
• 06958481454079: rev 02
• 06958481454062: rev 02