True-Comfort Safety Pen Needles 6MM 31G

GUDID 10850058864027

Safety Pen Needles 6MM 31G

HOME AIDE DIAGNOSTICS, INC.

Subcutaneous infusion/injection port needle

• Primary Device ID: 10850058864027
• NIH Device Record Key: d1825b88-b1c2-4e3a-9b0c-f324ae50091c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True-Comfort Safety Pen Needles 6MM 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
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us

Device Dimensions

• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 Millimeter
• Needle Gauge: 31 Gauge
• Length: 6 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• 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	00850058864020 [Primary]
GS1	10850058864027 [Package]; Contains: 00850058864020; Package: Case [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: 2024-10-16
• Device Publish Date: 2024-10-08

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