EXPRESS

GUDID 20650862115158

EXPRESS II, Single Collection, SFP (Express Dry Seal Chest Drain)

ATRIUM MEDICAL CORPORATION

Thoracic suction system

• Primary Device ID: 20650862115158
• NIH Device Record Key: 92364e10-40cd-4259-8381-98460ea90f73
• Commercial Distribution Discontinuation: 2017-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EXPRESS
• Version Model Number: 4000-170N
• 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	00650862115154 [Primary]
GS1	20650862115158 [Package]; Contains: 00650862115154; Package: [6 Units]; Discontinued: 2017-10-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043140

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [EXPRESS]

• 20650862199301: EXPRESS MINI 500 SUCTION BULB
• 20650862164002: EXPRESS MINI 500 DRAIN
• 20650862115219: EXPRESS, Dual Collection (Express Dry Seal Chest Drain)
• 20650862115165: EXPRESS II, BRU, SFP (Express Dry Seal Chest Drain - ATS)
• 20650862115158: EXPRESS II, Single Collection, SFP (Express Dry Seal Chest Drain)
• 20650862115141: EXPRESS DRAIN ,BRU, INLINE & ATS COMPATIBLE
• 20650862115134: EXPRESS DRAIN, SINGLE, INLINE & ATS COMPATIBLE