GUDID 20840682102920

GE Healthcare Finland Oy

Breathing circuit condensate trap, reusable

• Primary Device ID: 20840682102920
• NIH Device Record Key: 3be9958c-1e4a-465b-8d56-705fe2c62309
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Mini D-fend Water Trap, 8002174
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• 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	00840682102926 [Primary]
GS1	20840682102920 [Package]; Contains: 00840682102926; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051092

FDA Product Code

• BZK: Spirometer, monitoring (w/wo alarm)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-12

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