Omnifix® 339165

GUDID 04046964941153

PS5LFN 5ML SYR & FILTER NDL SET NRFIT

B. BRAUN MEDICAL INC.

Epidural/intrathecal anaesthesia set, non-medicated

• Primary Device ID: 04046964941153
• NIH Device Record Key: 68ebf2c2-0e39-4e47-a856-f4daa0c03810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnifix®
• Version Model Number: 339165
• Catalog Number: 339165
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 25
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964941146 [Unit of Use]
GS1	04046964941153 [Primary]

FDA Product Code

• FMF: Syringe, piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-11-14

On-Brand Devices [Omnifix®]

• 04046964723247: Syringe - Omnifix™, Luer Lock
• 04046964941177: PS20LFN 20ML LL SYR & FLTR NDL SET NRFIT
• 04046964941153: PS5LFN 5ML SYR & FILTER NDL SET NRFIT
• 04046964723285: OMNIFIX 50 ML CATHETER US
• 04046964723261: OMNIFIX 50 ML US
• 04046963452322: 10 mL LL 21 Ga. x 1-1/2 in.
• 04046955607815: OMNIFIX 2ML LL LDS,DISPLACEMENT SPIKE-US
• 04046955292011: OMNIFIX 1 ML LL LDS FINE DOSAGE US
• 04046955850839: OMNIFIX 3 ML US