UltraFlo Insulin Pen Needle

GUDID B7443357733

31G X 5/16" (8mm)

QUALITY MEDICAL PRODUCTS USA, INC.

Autoinjector needle

• Primary Device ID: B7443357733
• NIH Device Record Key: df06f49d-b6d8-4fd1-8bf0-caf7ea618857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraFlo Insulin Pen Needle
• Version Model Number: 335773
• Company DUNS: 054180248
• Company Name: QUALITY MEDICAL PRODUCTS USA, 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7443357730 [Unit of Use]
HIBCC	B7443357731 [Primary]
HIBCC	B7443357732 [Package]; Contains: B7443357731; Package: Inner Case [12 Units]; In Commercial Distribution
HIBCC	B7443357733 [Package]; Contains: B7443357732; Package: Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133059

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: 2020-01-20
• Device Publish Date: 2019-06-24

On-Brand Devices [UltraFlo Insulin Pen Needle]

• B7443357763: 33G x 5/32" (4mm)
• B7443357743: 32G X 5/32" (4mm)
• B7443357733: 31G X 5/16" (8mm)
• B7443357723: 31G X 3/16" (5mm)
• B7443357713: 29G X 1/2" (12mm)