HMG IV extension set CV100B

GUDID 00850048235069

7" IV Extension Set, macro bore with bonded needlefree valve

Hartman Medical Group LLC

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• Primary Device ID: 00850048235069
• NIH Device Record Key: b3a0f344-6e82-4cee-ad4e-440266cad4fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMG IV extension set CV100B
• Version Model Number: CV100B
• Company DUNS: 117654675
• Company Name: Hartman Medical Group 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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
GS1	00850048235069 [Primary]
GS1	60850048235061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150513

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2023-11-14
• Device Publish Date: 2023-11-06

On-Brand Devices [HMG IV extension set CV100B]

• 10850048235066: 7" IV Extension Set, macro bore with bonded needlefree valve
• 00850048235069: 7" IV Extension Set, macro bore with bonded needlefree valve
• 30850048235060: 7" IV Extension Set, macro bore with bonded needlefree valve