Simpli

GUDID 30357515745829

8mm 31G Pen Needle Box 120

ULTIMED, INC.

Autoinjector needle

• Primary Device ID: 30357515745829
• NIH Device Record Key: a3d7d9ff-a316-49ed-ba33-161258f66e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpli
• Version Model Number: 74582
• Company DUNS: 024723541
• Company Name: ULTIMED, INC.
• Device Count: 120
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357515710055 [Unit of Use]
GS1	20357515745822 [Primary]
GS1	30357515745829 [Package]; Contains: 20357515745822; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100812

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: 2020-05-11
• Device Publish Date: 2020-05-01

On-Brand Devices [Simpli]

• 30357515745836: 8mm 31G Pen Needle box 90ct
• 30357515745829: 8mm 31G Pen Needle Box 120
• 30357515745638: 6mm 32G Pen Needle Box 90ct
• 30357515745621: 6mm 32G Pen Needle Box 120
• 30357515745539: 5mm 31G Pen Needle box 90ct
• 30357515745522: 5mm 31G Pen Needle box 120
• 30357515745430: 4mm 32G Pen Needle Box 90ct
• 00357515710031: 4mm 32G pen needle box 90ct
• 30357515745058: Simpli 8mm Pen Needle UltiGuard
• 30357515745034: Simpli 6mm Pen Needle UltiGuard
• 30357515745027: Simpli 5mm Pen Needle UltiGuard
• 30357515745010: Simpli 4mm UltiGuard