TopRx 1st Tier UP

GUDID 00384703540002

TopRx 1st Tier UP Pentips - 4mmx32G

OWEN MUMFORD USA INCORPORATED

Autoinjector needle

• Primary Device ID: 00384703540002
• NIH Device Record Key: 097c866f-90e4-4535-855c-94dfbabd7eed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopRx 1st Tier UP
• Version Model Number: AN 3540TRX
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703540002 [Unit of Use]
GS1	00761059540878 [Primary]
GS1	00761059541875 [Package]; Contains: 00761059540878; Package: Sleeve [10 Units]; In Commercial Distribution
GS1	00761059542872 [Package]; Contains: 00761059541875; Package: Case [5 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-10
• Device Publish Date: 2022-06-02

On-Brand Devices [TopRx 1st Tier UP]

• 00761059590873: TopRx 1st Tier UP Pen needles - 6mm x 32G
• 00761059551874: TopRx 1st Tier UP Pentips - 5mm x 31G
• 00384703540002: TopRx 1st Tier UP Pentips - 4mmx32G
• 00761059531876: TopRx 1st Tier UP pen needles - 6mm x 32G
• 00761059420873: TopRx 1st Tier Pentips pen needles -12mm x 29G