Omnican® 931A04US

GUDID 04046955138043

OMNICAN FINE 31G x 4MM GLUED W/O CAP US

B. Braun Melsungen Aktiengesellschaft

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle

• Primary Device ID: 04046955138043
• NIH Device Record Key: 0780982e-7d63-4c89-ba7e-0af100346d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnican®
• Version Model Number: 931A04US
• Catalog Number: 931A04US
• Company DUNS: 315016972
• Company Name: B. Braun Melsungen Aktiengesellschaft
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955138043 [Unit of Use]
GS1	04046955143115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173803

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: 2021-12-09
• Device Publish Date: 2021-12-01

Devices Manufactured by B. Braun Melsungen Aktiengesellschaft

• 04046955138043 - Omnican®: 2021-12-09OMNICAN FINE 31G x 4MM GLUED W/O CAP US
• 04046955138043 - Omnican®: 2021-12-09 OMNICAN FINE 31G x 4MM GLUED W/O CAP US
• 04046964905063 - ACCEL®: 2019-11-06 2000ML EVACUATED DRAINAGE BOTTLE
• 04046955096763 - Subcutaneous Injection Supply Kit: 2019-10-23 The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical
• 04046964613371 - ACCEL®: 2019-04-29 1000ML DRAINAGE BOTTLE, PVC-FREE