Curaplex

GUDID 00815277021173

Curaplex Intraosseous (IO) Infusion Kit with Illinois Needle 16 Gauge

BOUND TREE MEDICAL, LLC

Intraosseous infusion kit

• Primary Device ID: 00815277021173
• NIH Device Record Key: 1e999d68-8fad-4947-9d04-36acf9c1892d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curaplex
• Version Model Number: 62241163S
• Company DUNS: 070556204
• Company Name: BOUND TREE MEDICAL, 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: false
• Expiration Date: false
• 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
GS1	00810094570460 [Package]; Package: CS [20 Units]; In Commercial Distribution
GS1	00815277021173 [Primary]

FDA Product Code

• OKE: Port introducer kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-14

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