FDA.reportPublic FDA data

Design Options®

Primary DI
04046955672370
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
560680
Catalog number
560680
Device description
COREWELL HEALTH
Published
2026-05-24
Public version status
New
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
OFUSpinal anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955672370PrimaryGS10
04046955672363Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955672370040469556723704046955672370
04046955672363040469556723634046955672363

GMDN Terms#

Term, Definition table
TermDefinition
Intrathecal anaesthesia set, medicatedA collection of devices intended for the single-administration of an analgesic or anaesthetic agent to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes the pharmaceutical anaesthetic agent, spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. 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
Storage Environment Humidity00
Storage Environment Temperature00

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
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
04046955745999Introcan Safety ® 24242007-024242007-022025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956359329CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956406801CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956421170CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956393347CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-19
50198956364620CARDINAL HEALTHCardinal Health 200, LLCOFU2026-02-09
50198956238730CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
50198956343601CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
50198956270747CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-29
50198956266511CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
04046955672028Design Options®B. BRAUN MEDICAL INC.OFU2025-12-22
04046961012641Design Options®B. BRAUN MEDICAL INC.OFU2025-08-31
50198956169591CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
50198956133691CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
50198956099638CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-20
50198956080650CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
04046955672004Design Options®B. BRAUN MEDICAL INC.OFU2025-04-27
50197106924134CARDINAL HEALTHCardinal Health 200, LLCOFU2025-04-03
50198956009651CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-31
50198956007244CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-25
50197106980246CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-14
50197106955466CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-11
50197106839353CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-10
50197106938513CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-28
50197106951987CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-21
50197106882953CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-03
50197106887279CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-30
50197106907328CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-30
50197106878611CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-21
50197106879694CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-06
50197106550951CARDINAL HEALTHCardinal Health 200, LLCOFU2024-10-28