HMG IV extension Sets CV300B

GUDID 00850048235106

5” (13cm) Micro Bore Trifurcated Extension Set Bonded Needleless Connectors

Hartman Medical Group LLC

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• Primary Device ID: 00850048235106
• NIH Device Record Key: 2b438d4e-b87a-4297-9154-7325400feed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMG IV extension Sets CV300B
• Version Model Number: CV300B
• Company DUNS: 117654675
• Company Name: Hartman Medical Group LLC
• Device Count: 600
• 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	00850048235106 [Unit of Use]
GS1	10850048235103 [Primary]
GS1	20850048235100 [Primary]
GS1	30850048235107 [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: 2024-02-26
• Device Publish Date: 2024-02-16

Devices Manufactured by Hartman Medical Group LLC

• 00850048235083 - HMG IV extension Sets CV100R: 2024-05-27 7” (18cm) Micro Bore IV Extension Set with Detachable Needleless Connector
• 00850048235090 - HMG IV extension Sets CV200B: 2024-02-26 7" IV Bifurcated Extension Set, micro bore with bonded needlefree valve
• 00850048235106 - HMG IV extension Sets CV300B: 2024-02-265” (13cm) Micro Bore Trifurcated Extension Set Bonded Needleless Connectors
• 00850048235106 - HMG IV extension Sets CV300B: 2024-02-26 5” (13cm) Micro Bore Trifurcated Extension Set Bonded Needleless Connectors
• 30850048235060 - HMG IV extension set CV100B: 2024-01-09 7" IV Extension Set, macro bore with bonded needlefree valve
• 30850048235077 - HMG IV extension sets CVM100B: 2024-01-09 7" IV Extension Set, micro bore with bonded needlefree valve
• 00850048235069 - HMG IV extension set CV100B: 2023-11-14 7" IV Extension Set, macro bore with bonded needlefree valve
• 10850048235066 - HMG IV extension set CV100B: 2023-11-14 7" IV Extension Set, macro bore with bonded needlefree valve
• 10850048235073 - HMG IV extension set CVM100B: 2023-11-14 7" IV Extension Set, micro bore with bonded needlefree valve