GUDID 00840682103596

GE Healthcare Finland Oy

Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable

• Primary Device ID: 00840682103596
• NIH Device Record Key: d778d9d1-89e0-4998-9376-ed3e0ecd3323
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Pedi-lite sensor, reusable, Pediatric
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682103596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051092

FDA Product Code

• CBR: ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-04
• Device Publish Date: 2016-06-16

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• 00195278201980 - PORTRAIT AAB01: 2023-09-11 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
• 00195278264794 - PORTRAIT SpO2 P-SP01: 2023-09-11 PORTRAIT SpO2 P-SP FINAL DEVICE ASSEMBLY