Unifine Ultra

GUDID 00384700130220

Unifine Ultra Pen Needle sample bag - 8mm x 31G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle

• Primary Device ID: 00384700130220
• NIH Device Record Key: 29da7f25-34a5-45a3-9614-5c45533543bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unifine Ultra
• Version Model Number: AN 0130SB2
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 2
• 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: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com
• Phone: 770-977-2226
• Email: USCustomerService@owenmumford.com

Device Dimensions

• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384700130213 [Primary]
GS1	00384700130220 [Package]; Contains: 00384700130213; Package: Case [500 Units]; In Commercial Distribution
GS1	00384704130004 [Unit of Use]

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: 2022-03-28
• Device Publish Date: 2022-03-18

On-Brand Devices [Unifine Ultra]

• 00384704190039: Unifine Ultra Pen Needles - 6mm x 31G
• 00384704150033: Unifine Ultra Pen Needle - 5mm x 31G
• 00384704140034: Unifine Ultra Pen Needles - 4mm x 32G
• 00384704130035: Unifine Ultra Pen Needles - 8mm x 31G
• 00384700140229: Unifine Ultra Pen Needles sample bag - 4mm x 32G
• 00384700190224: Unifine Ultra Pen Needle sample bag - 6mm x 31G
• 00384700150228: Unifine Ultra Pen Needle sample bag - 5mm x 31G
• 00384700130220: Unifine Ultra Pen Needle sample bag - 8mm x 31G