Haemonetics

GUDID 30887691000172

FILTER RC EZ PRIME W/S SET

HAEMONETICS CORPORATION

Blood transfusion filter

• Primary Device ID: 30887691000172
• NIH Device Record Key: 59891191-1246-4a7f-8e29-cc05cb368596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Haemonetics
• Version Model Number: RCEZKS
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887691000178 [Primary]
GS1	30887691000172 [Package]; Contains: 10887691000178; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873666

FDA Product Code

• CAK: Microfilter, blood transfusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-23
• Device Publish Date: 2022-03-15

On-Brand Devices [Haemonetics]

• 30887691312381: Transfer Bag 400ml with 6 Leads
• 30887691306373: Bacerial Detection System for Quality Control Testing of Platelet Products
• 30887691002954: Single Collection Unit without Anticoagulant
• 30887691002855: Transfer Bag 600 ml w/Y set
• 30887691002848: Transfer Bag 300 ml
• 10887691313940: High Efficiency Post-Process Filter System for Leukocyte Removal From Red Cells
• 30887691305796: LRF6 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 600 mL Transfer Bag
• 30887691305307: LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 L CLX Transfer
• 30887691003876: Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC
• 30887691003869: High Efficiency Rapid Flow Leukocyte Reduction Filter Set for Single Unit Blood Transfusion
• 30887691003852: PL High Efficiency Leukocyte Reduction Filter with Attached Y-Administration Set and Self-leveli
• 30887691003845: PL High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set and Self
• 30887691000752: BPF Leukocyte Reduction Filteration System
• 30887691000738: RS Leukocyte Reduction Filter for Intraoperatively Salvaged Washed Blood
• 30887691000707: LRF High Efficiency Leukocyte Reduction Filtration System for Platelets
• 30887691000684: Microaggregate Blood Transfusion Filter with Attached Y-Type Administration Set with 3 mm Tubing
• 30887691000677: Microaggregate Blood Transfusion Filter with Attached Straight Administration Set with 3 mm Tubi
• 30887691000431: LRF 10 High Efficiency Leukocyte Reduction Filter for platelets with Attached 1.3L CLX Transfer
• 30887691000424: LPS High Efficiency Leukocyte Reuction Filter for Plasma
• 30887691000110: PL High efficiency Leukocyte Reduction Filter for a Single Unit of Platelet Concentrate with Att
• 30887691000660: Blood Transfusion Filter
• 30887691000547: High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight Administration S
• 30887691000172: FILTER RC EZ PRIME W/S SET