FDA.reportPublic FDA data

Design Options®

Primary DI
04046955184156
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
552143
Catalog number
552143
Device description
CESK-SD BROOKWOOD MEDICAL CENTER
Published
2018-06-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGEEpidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955184156PrimaryGS10
04046955186433Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955184156040469551841564046955184156
04046955186433040469551864334046955186433

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
10
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955900268Design Options®5517695517692026-05-14
04046964308024Design Options®5517695517692016-09-23
04045928020392Design Options®5521235521232026-05-11
04045928020699Design Options®5521795521792026-05-11
04046955803125Clik-Fix®LLS-1021BLLS-1021B2023-01-06
04046955803163Clik-Fix®LLS-1024BLLS-1024B2023-01-06
04046955803194Clik-Fix®NPS-1006BNPS-1006B2022-12-22
04046955803231Clik-Fix®LLSK-1024BLLSK-1024B2023-01-06
04046955803255Clik-Fix®PCS-1011BPCS-1011B2022-12-22
04046955803286Clik-Fix®WCS-1000BWCS-1000B2023-03-13
04046955803316Clik-Fix®WCS-1003BWCS-1003B2023-03-06
04046955803347Clik-Fix®WCS-1006BWCS-1006B2023-01-06
04046955840878Clik-Fix®ECS-1000BECS-1000B2025-01-12
04046955840908Clik-Fix®ECS-2000BECS-2000B2024-12-08
04046961024811Blood Administration Set4700824700822026-05-10
04046964303326IV Administration Set4901734901732026-05-10
04046964727078EASYPUMP4434447-024434447-022016-09-23
04046964727139EASYPUMP4434455-024434455-022016-09-23
04046964183232Perifix®4150044150042016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956284980CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-24
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50198956413908CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-23
50198956290837CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-16
50198956369823CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
50198956382464CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
50198956393590CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-09
50198956378375CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-03
50198956347623CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-02
50198956391107CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-02
50198956329704CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956338645CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956341010CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956341157CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-23
50198956293906CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
50198956365597CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
50198956298024CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
50198956315981CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
50198956358056CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-09
04045928020866Design Options®B. BRAUN MEDICAL INC.OGE2026-02-03
04046955900534Perifix®B. BRAUN MEDICAL INC.OGE2026-02-03
04046955900855Design Options®B. BRAUN MEDICAL INC.OGE2026-02-03
50198956318340CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-26
50198956303902CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-23
50198956317152CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-22
50198956299144CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-15
00191072241689ACSAMERICAN CONTRACT SYSTEMS, INC.OGE2026-01-14
50198956180275CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-13
50198956316230CARDINAL HEALTHCardinal Health 200, LLCOGE2026-01-13