CLR CLR 2.0

GUDID 20860113000656

The SeaStar CLR 2.0 hemofilter is indicated for use in patients with fluid overload, uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

SEASTAR MEDICAL, INC.

Haemofilter

• Primary Device ID: 20860113000656
• NIH Device Record Key: 9947ad21-7436-4493-a059-cee2714436f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLR
• Version Model Number: 2.0
• Catalog Number: CLR 2.0
• Company DUNS: 081470300
• Company Name: SEASTAR 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8444278100
• Email: info@seastarmed.com

Device Dimensions

• Area/Surface Area: 1.98 Square meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	20860113000656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000028

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

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

[20860113000656]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-19
• Device Publish Date: 2019-06-11