True Comfort Safety Pen Needles 5MM 31G

GUDID 10850027494439

Safety Pen Needles 5MM 31G

HOME AIDE DIAGNOSTICS, INC.

Subcutaneous infusion/injection port needle

• Primary Device ID: 10850027494439
• NIH Device Record Key: 12391269-f51f-41f3-8cdd-e62275f09d72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Comfort Safety Pen Needles 5MM 31G
• Version Model Number: 1
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-915-0116
• Email: info@homeaide.us

Device Dimensions

• Needle Gauge: 31 Gauge
• Length: 5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027494432 [Primary]
GS1	10850027494439 [Package]; Contains: 00850027494432; Package: Outer Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192677

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2022-10-10
• Device Publish Date: 2022-09-30

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