HealthMart/UltiCare

GUDID 00357515710130

5mm Pen Needle UltiGuard

ULTIMED, INC.

Autoinjector needle

• Primary Device ID: 00357515710130
• NIH Device Record Key: 5a033dbb-2208-4bbe-9231-8ce9494ef2a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthMart/UltiCare
• Version Model Number: 1543057
• Company DUNS: 024723541
• Company Name: ULTIMED, INC.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357515710130 [Unit of Use]
GS1	20357515430575 [Primary]

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: 2020-06-23
• Device Publish Date: 2020-06-15

Devices Manufactured by ULTIMED, INC.

• 30357515745010 - Simpli: 2023-05-01 Simpli 4mm UltiGuard
• 30357515745027 - Simpli: 2023-05-01 Simpli 5mm Pen Needle UltiGuard
• 30357515745034 - Simpli: 2023-05-01 Simpli 6mm Pen Needle UltiGuard
• 30357515745058 - Simpli: 2023-05-01 Simpli 8mm Pen Needle UltiGuard
• 20357515460015 - UltiCare: 2023-03-09 1mL oral Syringe
• 20357515460039 - UltiCare: 2023-03-09 3mL oral syringe
• 10357515460056 - UltiCare: 2023-03-09 5mL oral syringe
• 20357515460107 - UltiCare: 2023-03-09 10mL oral syringe