Kalitec MAR0Max Convenience Kit

GUDID M89640K1000020

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M89640K1000020
• NIH Device Record Key: 7776b889-8bc4-4f69-a41f-09fc260303c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kalitec MAR0Max Convenience Kit
• Version Model Number: 40-K10-0002
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M89640K1000020 [Primary]

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: 2020-07-23
• Device Publish Date: 2019-04-23

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