GUDID 20840682102883

GE Healthcare Finland Oy

Breathing circuit condensate trap, reusable

• Primary Device ID: 20840682102883
• NIH Device Record Key: 6aa4654b-7a2a-49d2-b1a9-e17e41084578
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: D-fend Pro Water Trap, M1200227
• 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

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682102889 [Primary]
GS1	20840682102883 [Package]; Contains: 00840682102889; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150245

FDA Product Code

• CCL: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-22
• Device Publish Date: 2016-08-15

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