Curaplex

GUDID 00815277022958

Curaplex Select Male Adapter Plug, Luer Locking Site 100ea/cs

BOUND TREE MEDICAL, LLC

Luer/Luer linear connector, single-use

• Primary Device ID: 00815277022958
• NIH Device Record Key: 6f7963c3-7186-4e46-9e5f-eb1e15d31011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curaplex
• Version Model Number: 05-00100
• Company DUNS: 070556204
• Company Name: BOUND TREE MEDICAL, LLC
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815277022958 [Primary]
GS1	00815277022965 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970855

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

[00815277022958]

Ethylene Oxide

[00815277022958]

Ethylene Oxide

[00815277022958]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-12-14

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