Millex - FH

GUDID 04054839076473

MERCK MILLIPORE LIMITED

Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector Haemodialysis system transducer protector

• Primary Device ID: 04054839076473
• NIH Device Record Key: a35c61ce-3632-468b-91cc-fec8ac59883e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Millex - FH
• Version Model Number: SLFH1000N
• 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	04054839076473 [Primary]
GS1	04054839077968 [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 [Millex - FH]

• 04054839076473: SLFH1000N
• 04053252397837: SLFH1000N