LMA ATOMIZATION MAD600

GUDID 34026704613213

MADgic Atomizer with 3 mL Syringe

TELEFLEX INCORPORATED

Laryngotracheal anaesthesia applicator

• Primary Device ID: 34026704613213
• NIH Device Record Key: 8494e7e6-c556-42ca-81f6-cfc507d60fc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMA ATOMIZATION
• Version Model Number: IPN048838
• Catalog Number: MAD600
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	14026704613219 [Primary]
GS1	24026704613216 [Package]; Contains: 14026704613219; Package: Box [25 Units]; In Commercial Distribution
GS1	34026704613213 [Package]; Contains: 24026704613216; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153470

FDA Product Code

• CCT: APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA

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: 2017-10-27

On-Brand Devices [LMA ATOMIZATION]

• 25060112313138: MADomizer Disposable Tip
• 25060112313053: MAD Nasal without Syringe
• 34026704613152: MADomizer Mucosal Atomization Device
• 24026704626551: MADomizer Disposable Tip
• 24026704626544: MAD Nasal without Syringe
• 24026704613223: MADgic Atomizer without Syringe
• 34026704613213: MADgic Atomizer with 3 mL Syringe
• 34026704613206: MAD Nasal Atomization Device w/o 3cc Syringe
• 24026704613193: MADgic Pediatric without Syringe
• 24026704613186: MADgic Airway with 5 mL Syringe and Tubing
• 24026704613179: MADomizer Replacement Bottle Clip
• 24026704613162: MADomizer Pull Tab Cap
• 34026704613145: MAD Nasal with 3 mL Oral Syringe & Adapter
• 34026704613138: MAD Nasal with 3 mL Syringe & Adapter
• 34026704613121: MAD Nasal with 1 mL Syringe & Adapter
• 34026704613114: MAD Nasal with 1 mL Syringe
• 24026704613100: MAD Nasal with 3mL Syringe
• 34026704612827: MADomizer Disposable Tip: MAD510
• 34026704612810: MAD Nasal without Syringe: MAD300
• 34026704717584: MADomizer Disposable Tip
• 34026704717553: MADgic Pediatric without Syringe
• 34026704717546: MADgic Atomizer without Syringe
• 24026704717532: MADgic Atomizer with 3 mL Syringe
• 34026704717522: MAD Nasal without Syringe
• 24026704717518: MAD Nasal with 3 mL Oral Syringe & Adapter
• 24026704717501: MAD Nasal with 3 mL Syringe & Adapter
• 24026704717495: MAD Nasal with 1 mL Syringe & Adapter
• 34026704717485: MAD Nasal with 1 mL Syringe
• 24026704717471: MAD Nasal with 3mL Syringe
• 24026704709896: MAD Nasal without Syringe
• 24026704709889: MADgic Atomizer without Syringe
• 24026704709872: MADgic Atomizer with 3 mL Syringe
• 34026704709862: MADgic Pediatric without Syringe
• 34026704709855: MAD Nasal with 3 mL Oral Syringe & Adapter
• 34026704709848: MAD Nasal with 3 mL Syringe & Adapter
• 34026704709831: MAD Nasal with 1 mL Syringe & Adapter
• 24026704709827: MAD Nasal with 1 mL Syringe
• 34026704709817: MAD Nasal with 3mL Syringe