Sterilyte CL-02

GUDID 00814963020001

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate

• Primary Device ID: 00814963020001
• NIH Device Record Key: 79267fe1-2cdf-40c2-9733-56b9f0539ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilyte
• Version Model Number: CL-02
• Catalog Number: CL-02
• Company DUNS: 933721433
• Company Name: ROCKWELL MEDICAL, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	00814963020001 [Primary]
GS1	10814963020008 [Package]; Package: case [4 Units]; In Commercial Distribution
GS1	20814963020005 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971053

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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: 2015-09-15

On-Brand Devices [Sterilyte]

• 00814963020018: RL-01
• 00814963020001: CL-02