Omnican® 931G04S-02

GUDID 04046955064434

Omnican fine pen needle 31Gx4mm w cap US

B. BRAUN MEDICAL INC.

Autoinjector needle

• Primary Device ID: 04046955064434
• NIH Device Record Key: d282b817-ae66-49ac-bb02-41f1057f8e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnican®
• Version Model Number: 931G04S-02
• Catalog Number: 931G04S-02
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbra
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com
• Phone: +1(800)227-2862
• Email: BBMUS_Service.EmailOrders@bbraun.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955064410 [Unit of Use]
GS1	04046955064427 [Primary]
GS1	04046955064434 [Package]; Contains: 04046955064427; Package: Carton [10 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-04-22
• Device Publish Date: 2018-09-22

On-Brand Devices [Omnican®]

• 04046963456917: 1 mL TB 30 Ga. x -1/2 in. Permanent Needle
• 04046963456887: 1 mL Insulin 30 Ga. x -1/2 in. Permanent Needle
• 04046963456856: 1 mL Insulin 30 Ga. x 5/16 in. Permanent Needle
• 04046963456825: OMNICAN 100 1 ML INSULIN U-100 30GX12
• 04046963456795: OMNICAN 100 1 ML INSULIN U-100 30GX8
• 04046963456764: 0.5 mL Insulin 30 Ga. x -1/2 in. Permanent Needle
• 04046963456702: OMNICAN 50 0,5 ML INSULIN U-100 30GX12
• 04046963456672: 0.5 mL Insulin 30 Ga. x 5/16 in. Permanent Needle
• 04046955064434: Omnican fine pen needle 31Gx4mm w cap US
• 04046955064403: Omnican fine pen needle 31Gx6mm w cap US
• 04046955064373: Omnican fine pen needle 31Gx8mm w cap US
• 04046955064342: Omnican fine pen needle 29Gx12mm wcap US
• 04046963456634: OMNICAN 50 0,5 ML INSULIN U-100 30GX8