Aspira® 4992209/A

GUDID 10884450394905

Merit Medical Systems, Inc.

Pleural/peritoneal drainage catheterization kit

• Primary Device ID: 10884450394905
• NIH Device Record Key: e27d715c-fbcf-48ee-bd0e-4e57a655fc9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspira®
• Version Model Number: 00884450394908
• Catalog Number: 4992209/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: true
• 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 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450394908 [Primary]
GS1	10884450394905 [Package]; Contains: 00884450394908; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110396

FDA Product Code

• PNG: Peritoneal, drainage catheter for refractory ascites, long-term indwelling

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: 2020-01-03
• Device Publish Date: 2019-12-26

On-Brand Devices [Aspira®]

• 20884450394865: 00884450394861
• 10884450394981: 00884450394984
• 10884450394882: 00884450394885
• 10884450394899: 00884450394892
• 10884450394943: 00884450394946
• 10884450394912: 00884450394915
• 10884450398170: 00884450398173
• 10884450398163: 00884450398166
• 10884450394950: 00884450394953
• 10884450394936: 00884450394939
• 20884450394971: 00884450394977
• 10884450394905: 00884450394908
• 10884450394875: 00884450394878
• 10884450394967: 00884450394960
• 10884450394929: 00884450394922
• 10884450534301: 00884450534304
• 10884450534318: 00884450534311
• 10884450544997: 00884450544990
• 10884450544959: A