Omnican® 931A04US

GUDID 04046955138043

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

B. Braun Melsungen Aktiengesellschaft

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

• 04046955635832 - NORM-JECT®: 2025-07-22 10 ML NORM-JECT® LL BMS
• 04046955251711 - Subcutaneous Injection Supply Kit 2: 2025-01-17 The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical
• 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