Micro-Access Elite®

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name: Micro-Access Elite® FDA UDI
Generic Name: Vascular catheter introduction set, nonimplantable FDA UDI
Device Name: 5FX12CM MEH-018X50 SS/SS GW-7CM NDL FDA UDI
Model / Reference: 613351 FDA UDI
Description: 5FX12CM MEH-018X50 SS/SS GW-7CM NDL FDA UDI

Identifiers

Catalog Number: 613351 FDA UDI
Primary DI / UDI-DI: 04046964310027 FDA UDI
510(k) Number: K043525 FDA UDI
FDA Product Code: DYB FDA UDI
GMDN Term: Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Micro-Access Elite® by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: B Braun Interventional Systems, Inc

Sources (1)

FDA UDI f9f7a5c4-98da-4d8f-9a2f-7f8ac1c30f5c 38 fields · synced May 31, 2026

Micro-Access Elite®

Identity

Identifiers

Classification

Clinical & Handling

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)