Kinray 1st Tier Unifine Pentips Plus

GUDID 00761059841197

Kinray 1st Tier Unifine Pentips Plus - 4mm x 32G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle

• Primary Device ID: 00761059841197
• NIH Device Record Key: dd5579f8-8f8f-45ed-ac22-16ac93a209d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinray 1st Tier Unifine Pentips Plus
• Version Model Number: AN 3840KI
• 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: 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703840003 [Unit of Use]
GS1	00761059840190 [Primary]
GS1	00761059841197 [Package]; Contains: 00761059840190; Package: Sleeve [6 Units]; In Commercial Distribution
GS1	00761059842194 [Package]; Package: Case [4 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: 2
• Public Version Date: 2021-08-05
• Device Publish Date: 2020-09-18

On-Brand Devices [Kinray 1st Tier Unifine Pentips Plus]

• 00761059891192: Kinray 1st Tier Unifine Pentips Plus - 6mm x 31G
• 00761059851196: Kinray 1st Tier Unifine Pentips Plus - 5mm x 31G
• 00761059841197: Kinray 1st Tier Unifine Pentips Plus - 4mm x 32G
• 00761059831198: Kinray 1st Tier Unifine Pentips Plus - 8mm x 31G
• 00761059820192: Kinray 1st Tier Unifine Pentips Plus - 12mm x 29G