Hydromillex

GUDID 04054839076756

MERCK MILLIPORE LIMITED

Haemodialysis system transducer protector

• Primary Device ID: 04054839076756
• NIH Device Record Key: 9c400079-dcdf-494f-b2d8-24b239144d90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydromillex
• Version Model Number: SLST025DM
• Company DUNS: 896873994
• Company Name: MERCK MILLIPORE LIMITED
• Device Count: 1000
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04054839076756 [Primary]
GS1	04054839078163 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934069

FDA Product Code

• FIB: Protector, Transducer, Dialysis

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: 2016-09-01

On-Brand Devices [Hydromillex]

• 04054839076756: SLST025DM
• 04053252725180: SLST025DM