FDA.reportPublic FDA data

Design Options®

Primary DI
04046955625130
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
530185
Catalog number
530185
Device description
SESK COMBINED SPINAL AND EPIDURAL TRAY 2
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFTSpinal epidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955625147PrimaryGS10
04046955625130Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955625147040469556251474046955625147
04046955625130040469556251304046955625130

GMDN Terms#

Term, Definition table
TermDefinition
Epidural/intrathecal anaesthesia set, medicatedA dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe), and may include an epidural catheter for continuous-administration. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius40 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
50198956323443CARDINAL HEALTHCardinal Health 200, LLCOFT2026-02-09
04046955901197Combined Spinal & EpiduralB. BRAUN MEDICAL INC.OFT2026-02-03
50198956307795CARDINAL HEALTHCardinal Health 200, LLCOFT2025-12-31
20888277722276Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2025-12-18
50198956184037CARDINAL HEALTHCardinal Health 200, LLCOFT2025-08-27
40198459449063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459453657MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459461249MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459461256MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459468231MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459472924MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474379MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474386MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474393MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459474409MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459475451MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459475642MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459478292MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459478827MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
20809160492120Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFT2025-08-14
40198459446062MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459461263MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459463878MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459463885MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459464448MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459464479MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466244MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466350MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466411MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459467517MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11