Olympus

GUDID 15019778000879

KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED

Ultrasonic water bath Ultrasonic water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath Ultrasonic-cleaning water bath

• Primary Device ID: 15019778000879
• NIH Device Record Key: d696f225-ba2f-43e8-886c-0b8c19191c53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: Endosonic
• Company DUNS: 217061423
• Company Name: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
• 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: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019778000872 [Direct Marking]
GS1	15019778000879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K827508

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

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: 2016-09-19

On-Brand Devices [Olympus]

• 15019778005386: SSU-2
• 15019778005140: SSU-2
• 15019778004983: TC-C1
• 15019778004785: MAJ-172
• 15019778004716: MAJ-1651
• 15019778004709: MAJ-1652
• 15019778004655: WM-DP2
• 15019778004174: WM-DP2
• 15019778004112: WM-DP2
• 15019778004105: WM-NP2
• 15019778004099: WM-NP2
• 15019778004068: WM-NP2
• 15019778003733: WM-NP2
• 15019778003726: WM-NP2
• 15019778003672: WM-NP2
• 15019778003603: MAJ-1632
• 15019778003542: MAJ-1608
• 15019778003535: MAJ-1607
• 15019778003528: MAJ-1606
• 15019778003375: MAJ-1608
• 15019778003368: MAJ-1607
• 15019778003351: MAJ-1606
• 15019778003344: MAJ-1603
• 15019778003238: OFP-2 (ROW)
• 15019778003191: OFP-2 (US)
• 15019778002873: MAJ-178
• 15019778001982: TC-C2
• 15019778000879: Endosonic
• 05019778007444: TC-C3
• 05019778007376: TC-C3
• 05019778007239: TC-E410
• 05019778006669: TC-C4
• 05019778006652: TC-C4
• 05019778006614: TC-C4
• 05019778006560: TC-C4
• 05019778006553: TC-C4
• 05019778006515: TC-C4
• 05019778006508: TC-C4
• 05019778005211: TC-E300
• 05019778008557: WM-DP3 Mobile Workstation US 15A
• 05019778008489: WM-NP3 Mobile Workstation US 15A UR
• 05019778008472: WM-NP3 Moblie Workstation US 15A GI
• 05019778008465: WM-NP3 Mobile Workstation US 15A
• 05019778008144: WM-DP3 Mobile Workstation ROW
• 05019778008137: WM-DP3 Mobile Workstation US
• 05019778007901: WM-NP3 Mobile Workstation ROW URO
• 05019778007888: WM-NP3 Mobile Workstation US URO
• 05019778007857: WM-NP3 Mobile Workstation ROW GI
• 05019778007833: WM-NP3 Mobile Workstation US GI
• 05019778007802: WM-NP3 Mobile Workstation ROW