DAR 353U19004

GUDID 20884522032534

HME for Tracheostomized Patients

Covidien LP

Heat/moisture exchanger, single-use

• Primary Device ID: 20884522032534
• NIH Device Record Key: 46c6ece1-8ae5-4137-9760-cb2f27119ab8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAR
• Version Model Number: 353U19004
• Catalog Number: 353U19004
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, Keep dry, This side up

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884522032537 [Primary]
GS1	20884522032534 [Package]; Contains: 10884522032537; Package: CASE [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941535

FDA Product Code

• BYD: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

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: 2020-02-03
• Device Publish Date: 2018-08-19

On-Brand Devices [DAR]

• 30884522013011: Electrostatic Filter,Small, Angled Port
• 30884522012625: Adult-Pediatric Electrostatic Filter HME,Small, Angled Port
• 30884522012274: Adult-Pediatric Electrostatic Filter HME,Small, Tethered Cap
• 10884522037389: Adult-Pediatric Electrostatic Filter HME,Large
• 30884522013189: Electrostatic Spirometry Filter Angled Adapter
• 40884522012615: Adult-Pediatric Electrostatic Filter HME,Small
• 40884522012349: Adult-Pediatric Electrostatic Filter HME with Connector,Small, Tethered Cap
• 40884522012240: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Small
• 40884522012172: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large
• 10884522041980: Electrostatic Filter,Small
• 10884522039642: Adult-Pediatric Electrostatic Filter HME,Small
• 10884522039635: Adult-Pediatric Electrostatic Filter HME with Connector,Small
• 10884522038621: Infant-Pediatric Electrostatic Filter HME,Small
• 10884522038508: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large
• 10884522038492: Adult-Pediatric Electrostatic Filter HME with Connector,Large
• 10884522038485: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large
• 10884522038461: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large
• 10884522038447: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large
• 10884522038423: Adult-Pediatric Electrostatic Filter HME with Catheter Mount,Large
• 10884522037457: Adult-Pediatric Electrostatic Filter HME,Large
• 10884522035118: Adult-Pediatric Electrostatic Filter HME,Large, Tethered Cap
• 10884522033633: Adult-Pediatric Foam HME with Integrated Catheter Mount
• 10884522033312: Mechanical Filter,Small
• 10884522033275: Electrostatic Spirometry Filter
• 10884522032582: Electrostatic Filter,Large
• 10884522032292: Electrostatic Spirometry Filter Adapter
• 10884522032285: Mechanical Filter,Large
• 20884522032275: Electrostatic Spirometry Filter Adapter
• 10884522032261: Electrostatic Spirometry Filter Adapter
• 10884522032254: Electrostatic Spirometry Filter Adapter
• 10884522032247: Electrostatic Spirometry Filter Adapter
• 10884522032230: Electrostatic Spirometry Filter Adapter
• 20884522032220: Electrostatic Spirometry Filter Adapter
• 20884522032213: Electrostatic Spirometry Filter Adapter
• 10884522032209: Electrostatic Spirometry Filter Adapter
• 20884522032190: Electrostatic Spirometry Filter Adapter
• 20884522032183: Electrostatic Spirometry Filter Adapter
• 20884522032176: Electrostatic Spirometry Filter Adapter
• 10884522032162: Electrostatic Spirometry Filter Adapter
• 20884522032152: Electrostatic Spirometry Filter Adapter
• 10884522032148: Electrostatic Spirometry Filter Adapter
• 20884522032138: Electrostatic Spirometry Filter Adapter
• 10884522032124: Electrostatic Spirometry Filter Adapter
• 20884522032114: Electrostatic Spirometry Filter Adapter
• 10884522032100: Electrostatic Spirometry Filter Adapter
• 20884522032091: Electrostatic Spirometry Filter Adapter
• 20884522032084: Electrostatic Spirometry Filter Adapter
• 10884522032070: Electrostatic Spirometry Filter Adapter
• 20884522032060: Electrostatic Spirometry Filter Adapter
• 10884522032056: Electrostatic Spirometry Filter Adapter