Pure Comfort Insulin Pen Needles 32G 5mm 50cnt

GUDID 10860003125523

Insulin Pen Needles 32G 5mm 50cnt

HOME AIDE DIAGNOSTICS, INC.

Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use

• Primary Device ID: 10860003125523
• NIH Device Record Key: 62ade68d-100c-4da8-a9dc-fb591a691413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure Comfort Insulin Pen Needles 32G 5mm 50cnt
• Version Model Number: INSP32-5
• 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: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge
• Length: 4 Millimeter
• Needle Gauge: 32 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003125526 [Primary]
GS1	10860003125523 [Package]; Contains: 00860003125526; Package: Outer carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133058

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: 2020-03-05
• Device Publish Date: 2020-02-26

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

• 10850027494507 - True Support Neck Brace: 2023-11-13 Universal Neck Brace
• 10850027494514 - Smart Neb Pediatric Nebulizer: 2023-11-13 Smart Neb Pediatric Nebulizer
• 10850027494866 - True Comfort Safety Insulin Syringes 30g 1/2" 1/2cc: 2023-11-13 100 * Safety Insulin Syringes 30g 1/2" 1/2cc
• 10850027494873 - True Comfort Safety Insulin Syringes 30g 1/2" 1cc: 2023-11-13 100 * Safety Insulin Syringes 30g 1/2" 1cc
• 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