XCELL

GUDID B708XCBMCSC601

XCELL Bone Marrow Aspirate Concentration System 60ml, convenience kit.

APEX BIOLOGIX , LLC

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: B708XCBMCSC601
• NIH Device Record Key: 9ea7a1eb-e560-4b4d-b854-6a69b6767a6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XCELL
• Version Model Number: XC-BMC-SC-60
• Company DUNS: 079560357
• Company Name: APEX BIOLOGIX , LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• 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	B708XCBMCSC600 [Primary]
HIBCC	B708XCBMCSC601 [Package]; Contains: B708XCBMCSC600; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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: 2022-04-26
• Device Publish Date: 2022-04-18

On-Brand Devices [XCELL]

• B708XCPRP600: XCELL Platelet Concentrating System XC-PRP-60
• B708XCPRP60SUPP0: XCELL Platelet Concentrating System XC-PRP-60 Supplemental (accessory item)
• B708XCBMC60SUPP0: XCELL Bone Marrow Concentrating System XC-BMC-60 Supplemental
• B708XCBMC600: XCELL Bone Marrow Concentrating System XC-BMC-60
• B708XCPRPBDK10: Blood Draw Kit for XC-PRP-60 Platelet Concentrating System
• B708XCPPX601: XCELL Patient Pure X Blood Collection System 60ml
• B708XCBMSC601: XCELL Bone Marrow System 60ml, convenience kit Includes 1x XC-BMC-SC-60, Primary DI B708XCBMCSC
• B708XCBMCSC601: XCELL Bone Marrow Aspirate Concentration System 60ml, convenience kit.
• B708XCBMASC601: XCELL Bone Marrow Aspiration System 60ml, convenience kit.
• B708XCPSPC1201: XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
• B708XCPRP300: XCELL Platelet Concentrating System 30ml XC-PRP-30
• B708XCBMC301: XCELL Bone Marrow Aspirate Concentrating System 30ml XC-BMC-30