Azur Medical Company Inc.

GUDID 00860010450130

Azur Medical Company, Inc.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 00860010450130
• NIH Device Record Key: 4f978748-792e-4e0f-b610-a739fd48ece9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Azur Medical Company Inc.
• Version Model Number: PS1K01
• Company DUNS: 117537693
• Company Name: Azur Medical Company, Inc.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010450130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211211

FDA Product Code

• FMF: Syringe, Piston

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: 2023-07-11
• Device Publish Date: 2023-07-03

On-Brand Devices [Azur Medical Company Inc. ]

• 00860010450192: PCS10181K01
• 00860010450185: PCS52558K01
• 00860010450178: PCS3181K01
• 00860010450161: PCS12558K01
• 00860010450154: PS5K01
• 00860010450147: PS3K01
• 00860010450130: PS1K01
• 00860010450123: CS25101
• 00860010450116: CSB181H01
• 00860010450109: CS18101