Cell Freeze CML-75LN

GUDID 00817827023583

Cell Freeze Cryogenic Container Fill Range (50-90 mL)

CHARTER MEDICAL, LTD.

Blood/tissue storage/culture container

• Primary Device ID: 00817827023583
• NIH Device Record Key: 86d7ca21-b251-4229-a085-7b780e26003c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cell Freeze
• Version Model Number: CML-75LN
• Catalog Number: CML-75LN
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817827023088 [Primary]
GS1	00817827023583 [Package]; Contains: 00817827023088; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK060042

FDA Product Code

• LPZ: Container, Frozen Donor Tissue Storage

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-31
• Device Publish Date: 2021-08-23

On-Brand Devices [Cell Freeze]

• 00817827023583: Cell Freeze Cryogenic Container Fill Range (50-90 mL)
• 00817827023569: Cell Freeze Cryogenic Storage Container 750 mL Capacity
• 00817827023552: Cell Freeze Cryogenic Storage Container 50 mL Capacity
• 00817827025457: Cell Freeze Cryogenic Storage Container 500 mL Capacity
• 00817827023538: Cell Freeze Cryogenic Storage Container 500 mL Capacity
• 00817827023521: Cell Freeze Cryogenic Storage Container 250 mL Capacity
• 00817827023514: Cell Freeze Cryogenic Storage Container 250 mL Capacity