MASIMO 008-0654-00

GUDID 00732094034608

Masimo Disposable Adhesive Finger Clip Probe; Pediatric

WELCH ALLYN, INC.

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• Primary Device ID: 00732094034608
• NIH Device Record Key: a13b0de2-8917-497d-a1e9-f50f9c353b56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASIMO
• Version Model Number: 901012
• Catalog Number: 008-0654-00
• Company DUNS: 198227881
• Company Name: WELCH ALLYN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732094034608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902730

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-04
• Device Publish Date: 2021-04-26

Devices Manufactured by WELCH ALLYN, INC.

• 00732094355147 - Welch Allyn, Inc.: 2024-03-15 4.25mm UNIVERSAL SINGLE USE BOX OF 250
• 00732094355130 - Welch Allyn, Inc.: 2024-03-15 2.75mm UNIVERSAL SINGLE USE BOX OF 250
• 00817655023274 - Welch Allyn, Inc.: 2024-03-04 Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and
• 00732094315509 - Welch Allyn, Inc.: 2024-02-26 IFU USB WADCS ECG V2.X SOFTWARE
• 00732094315516 - Welch Allyn, Inc.: 2024-02-26 IFU USB WADCS SPIRO V2.X SOFTWARE
• 00732094355406 - Welch Allyn, Inc.: 2024-02-26 TRIAL WADCS SPIRO W CALIBR SYRINGE
• 00732094355413 - Welch Allyn, Inc.: 2024-02-26 TRIAL DCS RESTING ECG WITH WAM
• 00732094355420 - Welch Allyn, Inc.: 2024-02-26 TRIAL DCS RESTING ECG WITH AM12