Precise Sapphire

GUDID M896PRCSAP1201

Precise Sapphire - 120 mL LR Kit

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896PRCSAP1201
• NIH Device Record Key: 50804903-fedd-4b35-8cc1-d38006bdfe5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise Sapphire
• Version Model Number: PRC-SAP-120
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• 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: 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896PRCSAP1200 [Primary]
HIBCC	M896PRCSAP1201 [Package]; Contains: M896PRCSAP1200; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK200540

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-07
• Device Publish Date: 2023-05-30

Devices Manufactured by ARTERIOCYTE MEDICAL SYSTEMS, INC.

• M896IFLXMAX020 - Magellan Influx: 2023-06-14 MAR0 Kit with 2.5cc Influx Max
• M896AMS500220500 - Precise: 2023-06-07 Precise Separation Canister, 60 mL
• M896AMS500220530 - Precise: 2023-06-07 Precise Separation Canister, 60mL
• M896AMS500220560 - Precise: 2023-06-07 Precise Separation Canister, 60 mL
• M896AMS500350500 - Precise: 2023-06-07 Precise Separation Canister, 120 mL
• M896AMS500350530 - Precise: 2023-06-07 Precise Separation Canister, 120 mL
• M896AMS500350560 - Precise: 2023-06-07 Precise Separation Canister, 120 mL
• M896PRCDIA0600 - Precise Diamond: 2023-06-07 Precise Diamond - 60 mL LP Kit