CAP

GUDID 04953170054389

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic device sterilization/disinfection tubing set Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable

• Primary Device ID: 04953170054389
• NIH Device Record Key: 91f7e9b4-b7fa-4adc-aefa-e922b8263e99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAP
• Version Model Number: MH-365
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 6
• 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: true
• Serial Number: false
• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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
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• Phone: +1(800)401-1086
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• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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
• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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	04953170054389 [Primary]
GS1	84953170054385 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944201

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-21

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