HMG IV extension Sets CV100B

GUDID 20850048235063

7" IV Extension Set, macro bore with bonded needlefree valve CV100B

Hartman Medical Group LLC

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 20850048235063
• NIH Device Record Key: 2c7c3ba4-0a9a-40b3-b31a-5f78201f428e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMG IV extension Sets 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	20850048235063 [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

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: 2024-02-26 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