FDA.reportPublic FDA data

Design Options®

Primary DI
04046955125128
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
552140
Catalog number
552140
Device description
CESK-SD ADENA PAIN CENTER
Published
2017-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
04046955125128PrimaryGS10
04046955125111Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955125128040469551251284046955125128
04046955125111040469551251114046955125111

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50198956369823CARDINAL HEALTHCardinal Health 200, LLCOGE2026-03-10
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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
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50198956293906CARDINAL HEALTHCardinal Health 200, LLCOGE2026-02-13
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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