Nellcor

GUDID 20884522039717

Forehead SpO2 Sensor

Covidien LP

Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Transcutaneous blood gas monitor sensor Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use

• Primary Device ID: 20884522039717
• NIH Device Record Key: 7177f077-d128-4f16-b263-f2cbc875ba66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nellcor
• Version Model Number: MAXFAST
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10884522039710 [Primary]
GS1	20884522039717 [Package]; Contains: 10884522039710; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012891

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-30
• Device Publish Date: 2016-09-24

On-Brand Devices [Nellcor]

• 30884522043667: Adult-Neonatal Adhesive Sensor Wrap
• 30884522000813: Pediatric SpO2 Sensor
• 10884522042710: Adult SpO2 Sensor,Reusable
• 20884522001141: Neonatal-Adult SpO2 Sensor
• 20884522000908: Infant SpO2 Sensor
• 20884522000854: Adult XL SpO2 Sensor
• 20884522000847: Adult SpO2 Sensor
• 10884521080553: Headband RS10 Sensor
• 10884522043038: Sensor Extension Cable,Unterminated,Caution: For manufacturing, processing, or repacking
• 10884522042826: Pediatric-Infant SpO2 Sensor with Wraps
• 10884522042789: Pulse Oximetry Interface Cable,Unterminated,Caution: For manufacturing, processing or repacking.
• 10884522042680: Pediatric SpO2 Sensor Clip,Reusable
• 10884522042659: Sensor Cable
• 10884522042611: Neonatal SpO2 Sensor,Non-Adhesive
• 10884522042543: SpO2 Sensor,Multisite Reusable
• 30884522042530: Pediatric-Infant Adhesive Sensor Wrap
• 10884522042451: Adult SpO2 Sensor,Non-Adhesive
• 10884522042437: Neonatal SpO2 Sensor,Non-Adhesive
• 10884522042420: Pulse Oximetry Interface Cable
• 10884522042314: Pediatric SpO2 Sensor
• 10884522042307: Pediatric SpO2 Sensor
• 10884522042291: Pediatric SpO2 Sensor
• 10884522042284: Pediatric SpO2 Sensor
• 10884522042277: Pediatric SpO2 Sensor,Remanufactured
• 10884522042260: Adult XL SpO2 Sensor
• 10884522042185: Adult XL SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien l
• 10884522042178: Pediatric SpO2 Sensor,Two Piece
• 10884522042161: Neonatal-Adult SpO2 Sensor,Two Piece
• 10884522042154: Neonatal-Adult SpO2 Sensor,Two Piece
• 10884522042147: Pediatric SpO2 Sensor,Two Piece
• 10884522042130: Adult SpO2 Sensor,Two Piece
• 10884522042123: Adult SpO2 Sensor Two Piece
• 10884522042116: Infant SpO2 Sensor,Two Piece
• 10884522041720: Neonatal-Adult SpO2 Sensor
• 10884522041713: Neonatal-Adult SpO2 Sensor
• 10884522041287: Infant SpO2 Sensor
• 10884522041270: Infant SpO2 Sensor
• 10884522040945: Infant SpO2 Sensor
• 10884522040891: Infant SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc
• 10884522040884: Infant SpO2 Sensor
• 10884522040389: Adult SpO2 Nasal Sensor
• 10884522040372: Neonatal-Adult SpO2 Sensor
• 10884522040310: Adult SpO2 Nasal Sensor
• 10884522040303: Adult SpO2 Nasal Sensor
• 10884522040105: Adult SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc
• 10884522040099: Adult SpO2 Sensor
• 10884522040082: Adult SpO2 Sensor
• 10884522040075: Adult SpO2 Sensor
• 10884522039697: Forehead SpO2 Sensor
• 10884521617476: Flexible SpO2 Reusable Sensor, Homecare, Small