Quantum Cell Inlet Bag 0.5L

GUDID 35020583210203

Cell Inlet Accessory Set - 004203-051

TERUMO BCT, INC.

Blood/tissue storage/culture container Blood/tissue storage/culture container

• Primary Device ID: 35020583210203
• NIH Device Record Key: 8894d53b-758a-4053-b57a-9e7700c11f50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Cell Inlet Bag 0.5L
• Version Model Number: 21020
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 10
• DM Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583210202 [Unit of Use]
GS1	35020583210203 [Primary]

FDA Product Code

• KJF: SYSTEM, SUSPENSION, CELL CULTURE

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: 2018-03-29
• Device Publish Date: 2016-09-15

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