FDA.report

Design Options®

Primary DI
04046964306136
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
530151
Catalog number
530151
Device description
Combined Spinal/Epidural Tray
Published
2016-09-23
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

Related Records

Contact Domains

Product Codes

CodeName
OFTSpinal epidural anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964306136PrimaryGS10
04046964306129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964306136040469643061364046964306136
04046964306129040469643061294046964306129

GMDN Terms

TermDefinition
Epidural/intrathecal anaesthesia set, non-medicatedA dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes 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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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
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 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 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