HMG

GUDID 00850048235014

Blood Collection Device-Male Luer Adapter

Hartman Medical Group LLC

Blood collection set, noninvasive

• Primary Device ID: 00850048235014
• NIH Device Record Key: fe75d664-e25e-42df-a66f-18042e7ba516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMG
• Version Model Number: 1
• Company DUNS: 117654675
• Company Name: Hartman Medical Group LLC
• Device Count: 800
• 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	00850048235014 [Unit of Use]
GS1	10850048235011 [Primary]
GS1	20850048235018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172763

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

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: 2023-05-03
• Device Publish Date: 2023-04-25

On-Brand Devices [HMG]

• 10850048235004: Electrode, Electrocardiograph-40 Pouches of 50
• 00850048235007: Electrode, electrocardiograph-Pouch of 50
• 00850048235021: Blood Collection Device-Female Luer Adapter
• 00850048235014: Blood Collection Device-Male Luer Adapter
• 00850048235052: Macro Bore IV extension set with Needle less Y-site and removable needless connector