Micro-Access Elite® 613358

GUDID 04046964310164

6FX5.5CM MEH-018X40 NT/AU GW-7CM NDL

B BRAUN INTERVENTIONAL SYSTEMS, INC

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• Primary Device ID: 04046964310164
• NIH Device Record Key: e4afcdb9-58c4-484f-9b22-7715c062f52c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro-Access Elite®
• Version Model Number: 613358
• Catalog Number: 613358
• Company DUNS: 784259751
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, 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: true
• 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(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *STORE AT ROOM TEMPERATURE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964310164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043525

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2019-06-07
• Device Publish Date: 2016-08-09

On-Brand Devices [Micro-Access Elite®]

• 04046964310492: 7FX5.5CM MEH W/MB018X40 NT/AU GW-7CM NDL
• 04046964310485: 7FX12CM MEH-018X50 SS/SS GW-4CM NDL
• 04046964310461: 7FX12CM MEH-018X50 NT/AU GW-4CM NDL
• 04046964310447: 7FX5.5CM MEH-018X40 NT/AU GW-4CM NDL
• 04046964310423: 7FX5.5CM MEH-018X40 SS/SS GW-4CM NDL
• 04046964310393: 7FX5.5CM MEH W/MB018X40 NT/AU GW-4CM NDL
• 04046964310379: 7FX12CM MEH-018X50 SS/SS GW-7CM NDL
• 04046964310355: 7FX12CM MEH-018X50 NT/AU GW-7CM NDL
• 04046964310348: 7FX5.5CM MEH-018X40 NT/AU GW-7CM NDL
• 04046964310324: 7FX5.5CM MEH-018X40 SS/SS GW-7CM NDL
• 04046964310300: 6Fx5.5CM MEH W/MB018x40 NT/AU GW-7CM NDL
• 04046964310287: 6FX12CM MEH-018X50 NT/AU GW-4CM NDL
• 04046964310263: 6FX12CM MEH-018X50 SS/SS GW-4CM NDL
• 04046964310249: 6FX5.5CM MEH-018X40 NT/AU GW-4CM NDL
• 04046964310225: 6FX5.5CM MEH W/MB018X40 NT/AU GW-4CM NDL
• 04046964310201: 6FX12CM MEH-018X50 NT/AU GW-7CM NDL
• 04046964310188: 6FX12CM MEH-018X50 SS/SS GW-7CM NDL
• 04046964310164: 6FX5.5CM MEH-018X40 NT/AU GW-7CM NDL
• 04046964310140: 5FX12CM MEH-018X50 SS/SS GW-4CM NDL
• 04046964310126: 5FX12CM MEH-018X50 NT/AU GW-4CM NDL
• 04046964310102: 5FX5.5CM MEH-018X40 SS/SS GW-4CM NDL
• 04046964310089: 5FX5.5CM MEH-018X40 NT/AU GW-4CM NDL
• 04046964310065: 5FX5.5CM MEH W/MB018X40 NT/AU GW-7CM NDL
• 04046964310041: 5FX5.5CM MEH W/MB-018X40 NT/AU GW-4CM ND
• 04046964310027: 5FX12CM MEH-018X50 SS/SS GW-7CM NDL
• 04046964310003: 5FX12CM MEH-018X50 NT/AU GW-7CM NDL
• 04046964309977: 5FX5.5CM MEH-018X40 SS/SS GW-7CM NDL
• 04046964309960: 5FX5.5CM MEH-018X40 NT/AU GW-7CM NDL
• 04046964309946: 4FX12CM MEH-018X50 SS/SS GW-4CM NDL
• 04046964309922: 4FX5.5CM MEH-018X40 SS/SS GW-4CM NDL
• 04046964309908: 4FX12CM MEH-018X50 NT/AU GW-4CM NDL
• 04046964309885: 4FX5.5CM MEH-018X40 NT/AU GW-4CM NDL
• 04046964309861: 4FX12CM MEH-018X50 SS/SS GW-7CM NDL
• 04046964309847: 4FX5.5CM MEH-018X40 SS/SS GW-7CM NDL
• 04046964309823: 4FX12CM MEH-018X50 NT/AU GW-7CM NDL
• 04046964309809: 4FX5.5CM MEH-018X40 NT/AU GW-7CM NDL