APC-120 Procedure Pack

GUDID 35020583514080

APC-120 Procedure Pack

TERUMO BCT, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 35020583514080
• NIH Device Record Key: 5a095811-5428-4d58-83ae-caddd5356da2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APC-120 Procedure Pack
• Version Model Number: 51408
• Company DUNS: 801679200
• Company Name: TERUMO BCT, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• 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: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com
• Phone: +1(303)205-2510
• Email: FDAUDIprogram@terumobct.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583514089 [Unit of Use]
GS1	35020583514080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120038

FDA Product Code

• ORG: Platelet and plasma separator for bone graft handling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-15

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• 35020583700315 - Accessory Platelet Bag with Integrated Sampler: 2022-12-01 elabeling.terumobct.com
• 05020583112209 - Spectra Optia®: 2022-09-01 Single-Needle Connector
• 05020583122208 - Spectra Optia®: 2022-09-01 Exchange Sets
• 05020583700703 - Platelet Additive Solution Connection Adapter: 2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER
• 05020583705005 - COBE® Spectra: 2022-09-01 Therapeutic Plasma Exchange Set