GUDID 00840682104463

GE Healthcare Finland Oy

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00840682104463
• NIH Device Record Key: 224b29ac-c5ed-4350-a375-749b700b90af
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2040427-002
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682104463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131414

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

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: 2016-07-22

Devices Manufactured by GE Healthcare Finland Oy

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• 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