AIRWAY MOBILESCOPE

GUDID 04953170407260

OLYMPUS MEDICAL SYSTEMS CORP.

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• Primary Device ID: 04953170407260
• NIH Device Record Key: c4ebf35d-cdfd-42d1-a147-8bb41fcfa303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRWAY MOBILESCOPE
• Version Model Number: OLYMPUS MAF-DM2
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170407260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201300

FDA Product Code

• EOQ: Bronchoscope (flexible or rigid)

Sterilization

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

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

[04953170407260]

High-level Disinfectant;Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [AIRWAY MOBILESCOPE]

• 04953170340369: MAF-GM AIRWAY MOBILESCOPE-INTUBATION
• 04953170288661: OLYMPUS MAF TYPE GM
• 04953170288630: MAF-TM AIRWAY MOBILESCOPE-TREATMENT/ ASP
• 04953170407260: OLYMPUS MAF-DM2
• 04953170407208: OLYMPUS MAF-GM2
• 04953170407147: OLYMPUS MAF-TM2