Nellcor D20

GUDID 30884522000813

Pediatric SpO2 Sensor

Covidien LP

Transcutaneous blood gas monitor sensor

• Primary Device ID: 30884522000813
• NIH Device Record Key: 6f650d78-bfca-4096-bbbe-20f62cf47a9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nellcor
• Version Model Number: D20
• Catalog Number: D20
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	30884522000813 [Package]; Contains: 40884522000810; Package: CASE [24 Units]; In Commercial Distribution
GS1	40884522000810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993637

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: 2018-07-31
• 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