Unifine Pentips Plus - 8mm x 31G AN3830

GUDID 00384703830035

For use with injectors for the subcutaneous injection of approved drugs, including insulin

OWEN MUMFORD USA INCORPORATED

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle

• Primary Device ID: 00384703830035
• NIH Device Record Key: 5485435c-1c4c-4f85-a892-673733b95bb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unifine Pentips Plus - 8mm x 31G
• Version Model Number: AN3830
• Catalog Number: AN3830
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 100
• 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: false
• 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: true

Customer Support Contacts

• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com
• Phone: 770-977-2226
• Email: info@owenmumfordinc.com

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter
• Needle Gauge: 31 Gauge
• Length: 8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703830001 [Unit of Use]
GS1	00384703830004 [Unit of Use]
GS1	00384703830011 [Primary]
GS1	00384703830028 [Package]; Contains: 00384703830011; Package: Sleeve [6 Units]; In Commercial Distribution
GS1	00384703830035 [Package]; Contains: 00384703830028; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152339

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [Unifine Pentips Plus - 8mm x 31G]

• 00384703830035: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384702830036: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830915: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830816: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830717: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830618: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830519: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830410: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830311: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830212: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700830038: For use with injectors for the subcutaneous injection of approved drugs, including insulin