RM3 Tool Kit 3910001.004

GUDID B154R39100010043

RM3 Tool Kit

WATERS MEDICAL SYSTEMS, LLC

Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set Kidney donor-organ preservation/transport perfusion set

• Primary Device ID: B154R39100010043
• NIH Device Record Key: 91f2c804-3a6f-4061-8fd1-ff414755e0f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RM3 Tool Kit
• Version Model Number: RM3 Tool Kit
• Catalog Number: 3910001.004
• Company DUNS: 556957871
• Company Name: WATERS MEDICAL SYSTEMS, LLC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B154R39100010043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971571

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-03-27

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