PNEUMOSTAT

GUDID 20650862161001

PNEUMOSTAT CHEST DRAIN VALVE

ATRIUM MEDICAL CORPORATION

Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle Closed-wound/centesis drainage receptacle

• Primary Device ID: 20650862161001
• NIH Device Record Key: d665735b-4fd5-4714-b893-88841d045f37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUMOSTAT
• Version Model Number: 16100
• Company DUNS: 051798999
• Company Name: ATRIUM MEDICAL CORPORATION
• 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	00650862161007 [Primary]
GS1	20650862161001 [Package]; Contains: 00650862161007; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984496

FDA Product Code

• KDQ: BOTTLE, COLLECTION, VACUUM

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: 2019-01-10
• Device Publish Date: 2015-09-24

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• 00650862426168 - iCast Covered Stent System, 6mmX16mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX16mmX120cm
• 00650862426229 - iCast Covered Stent System, 6mmX22mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX22mmX120cm
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