True Comfort Safety Pen Needles 4MM 32G

GUDID 10850027494446

Safety Pen Needles 4MM 32G

HOME AIDE DIAGNOSTICS, INC.

Subcutaneous infusion/injection port needle

• Primary Device ID: 10850027494446
• NIH Device Record Key: 503ff46e-f9a0-4101-85a9-dbe255533b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Comfort Safety Pen Needles 4MM 32G
• 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: 32 Gauge
• Length: 4 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	00850027494449 [Primary]
GS1	10850027494446 [Package]; Contains: 00850027494449; 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

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

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• 10850027494880 - True Comfort Safety Insulin Syringes 30g 5/16'' 1/2cc: 2023-11-13 100 * Safety Insulin Syringes 30g 5/16'' 1/2cc
• 10850027494897 - True Comfort Safety Insulin Syringes 30g 5/16'' 1cc: 2023-11-13 100 * Safety Insulin Syringes 30g 5/16'' 1cc
• 10850027494903 - True Comfort Safety Insulin Syringes 31g 5/16" 1/2cc: 2023-11-13 100 * Safety Insulin Syringes 31g 5/16" 1/2cc
• 10850027494910 - True Comfort Safety Insulin Syringes 31g 5/16" 1cc: 2023-11-13 100 * Safety Insulin Syringes 31g 5/16" 1cc