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Accel®

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
ACCEL® FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
3 PC, 018X60 NIT-GOLD, 038 GW, 21GA TROC FDA UDI
Model / Reference
612140 FDA UDI
Description
3 PC, 018X60 NIT-GOLD, 038 GW, 21GA TROC FDA UDI

Identifiers

Catalog Number
612140 FDA UDI
Primary DI / UDI-DI
04046955237548 FDA UDI
FDA Product Code
OFL FDA UDI
PXU FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular catheter introduction set, nonimplantable

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

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI b4134eb9-8e34-4138-b754-c88f8e420e9d 37 fields · synced Jun 1, 2026