Advect CT-018-90

GUDID 00817827026706

Fluid Transfer Sets 6" PVC with Spike Adapter and Luer

CHARTER MEDICAL, LTD.

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• Primary Device ID: 00817827026706
• NIH Device Record Key: eea40425-898c-4c8a-8b3a-cbdb451cad27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advect
• Version Model Number: CT-018-90
• Catalog Number: CT-018-90
• Company DUNS: 029062325
• Company Name: CHARTER MEDICAL, LTD.
• 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: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com
• Phone: (866) 458-3116
• Email: CML_CustomerService@CharterMedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817827026201 [Primary]
GS1	00817827026706 [Package]; Contains: 00817827026201; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK170004

FDA Product Code

• KSB: Set, Transfer (Blood/Plasma)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-24
• Device Publish Date: 2019-02-01

On-Brand Devices [Advect]

• 00817827026713: Fluid Transfer Sets 6" PVC with Spike and Male Luer
• 00817827026706: Fluid Transfer Sets 6" PVC with Spike Adapter and Luer
• 00817827026690: Fluid Transfer Sets 6" PVC - Spike with Female Luer and Twist off
• 00817827026683: Fluid Transfer Sets 10 Lead Harness with Port Adapter (6" L)
• 00817827026676: Fluid Transfer Sets 8 Lead Harness with Port Adapter (6" L)