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Design Options®

FDA UDI

Class II (US FDA UDI)

by B. Braun Medical Inc.

Identity

Trade Name
Design Options® FDA UDI
Generic Name
Epidural/intrathecal anaesthesia set, medicated FDA UDI
Device Name
SESK BEAUMONT ROYAL OAK FDA UDI
Model / Reference
530188 FDA UDI
Description
SESK BEAUMONT ROYAL OAK FDA UDI

Identifiers

Catalog Number
530188 FDA UDI
Primary DI / UDI-DI
04046955625208 FDA UDI
FDA Product Code
OFT FDA UDI
GMDN Term
Epidural/intrathecal anaesthesia set, medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 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

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Epidural/intrathecal anaesthesia set, medicated

Design Options® by B. Braun Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epidural/intrathecal anaesthesia set, medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B. Braun Medical Inc.

Sources (1)

  • FDA UDI ecf23f9a-7031-4a9d-b175-755c445c784f 37 fields · synced May 30, 2026