MAX-100

GUDID B641MAX10055

Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determination of total blood and plasma volumes.

DAXOR CORPORATION

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• Primary Device ID: B641MAX10055
• NIH Device Record Key: bb0c5905-0dd7-4abc-bd27-a1efbb675dd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAX-100
• Version Model Number: MAX-100 Syringe
• Company DUNS: 790888833
• Company Name: DAXOR CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B641MAX10055 [Primary]

FDA Product Code

• FMF: Syringe, Piston

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [MAX-100]

• B641MAX1004: Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin inject
• B641MAX10055: Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determin