easycare 4818-80000

GUDID 00850015884610

Safety Subcutaneous Hydration Kit (HydoDermoClysis)

Synchronis Medical, LLC

Peripheral intravenous catheterization support kit

• Primary Device ID: 00850015884610
• NIH Device Record Key: e9c328db-0019-433d-a7d1-2dd59df72c24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easycare
• Version Model Number: 4818-80000
• Catalog Number: 4818-80000
• Company DUNS: 080160207
• Company Name: Synchronis Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com
• Phone: 800.860.6664
• Email: omni@omnimedicalsupply.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015884603 [Primary]
GS1	00850015884610 [Package]; Contains: 00850015884603; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• LRS: I.V. Start Kit

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [easycare]

• 00850015884184: IV Start Kit w/3M™ Tegaderm™ #1683 Adv Securement & ChloraPrep™ 1mL
• 00850015884177: IV Start Kit w/3M™ Tegaderm™ #1614 w/Notch & ChloraPrep™ 1mL
• 00850015884160: IV Start Kit w/3M™ Tegaderm™ #1633 Split Tail & PDI Prevantics® Swab
• 00850015884153: IV Start Kit w/3M™ Tegaderm™ #1624 & PDI Prevantics® Swab
• 00850015884269: IV Start Kit w/18ga Safety Cath
• 00850015884610: Safety Subcutaneous Hydration Kit (HydoDermoClysis)
• 00850015884863: IV Start Kit w/8" Ext Set w/Pinch Clamp and PRN