Unifine Pentips - 5mm x 31G AN0550SB10

GUDID 00384700550011

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle

• Primary Device ID: 00384700550011
• NIH Device Record Key: 334db8b4-50b4-4219-b5e2-7b49ca5c57bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unifine Pentips - 5mm x 31G
• Version Model Number: AN0550SB10
• Catalog Number: AN0550SB10
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 10
• 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: false
• 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

Device Dimensions

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Length: 5 Millimeter
• Needle Gauge: 31 Gauge

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384700550001 [Unit of Use]
GS1	00384700550011 [Primary]
GS1	00384700550035 [Package]; Package: Case [100 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 - 5mm x 31G]

• 00384703550018: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384703450011: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384702050014: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384701150012: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550912: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550813: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550714: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550615: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550516: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550417: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550318: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550219: For use with injectors for the subcutaneous injection of approved drugs, including insulin
• 00384700550011: For use with injectors for the subcutaneous injection of approved drugs, including insulin