GUDID 00840682103305

GE Healthcare Finland Oy

Basic skin adhesive tape Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone Dressing-fixation skin adhesive tape, non-silicone

• Primary Device ID: 00840682103305
• NIH Device Record Key: 89f442a2-8f06-4da7-b617-c2f874c24215
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: OXY-RTW
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682103305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040831

FDA Product Code

• DPZ: Oximeter, ear

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: 2019-10-23
• Device Publish Date: 2016-06-24

Devices Manufactured by GE Healthcare Finland Oy

• 00195278229229 - PORTRAIT RRP01: 2024-01-03 BODY-WORN RESP ELECTRODE PATCH
• 00195278699916 - PORTRAIT AAB01: 2023-11-03 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
• 00195278699923 - PORTRAIT MMP01: 2023-11-03 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
• 00195278093998 - PORTRAIT HUB01: 2023-09-11 HUB, AMBULATORY HUB DEVICE ASSEMBLY
• 00195278094001 - PORTRAIT BCH01: 2023-09-11 CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
• 00195278110435 - PORTRAIT MMP01: 2023-09-11 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
• 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