FDA.reportPublic FDA data

Design Options®

Primary DI
04046964813993
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
530160
Catalog number
530160
Device description
Combined Spinal/Epidural Tray
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
04046964813993PrimaryGS10
04046964813986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964813993040469648139934046964813993
04046964813986040469648139864046964813986

GMDN Terms#

Term, Definition table
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#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
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
04022495101211Stimuplex®489426048942602016-09-23
04046955966295Design Options®5522105522102026-10-18
04022495101167Stimuplex®489425148942512016-09-23
04022495101266Stimuplex®489427848942782016-09-23
04022495101310Stimuplex®489450248945022016-09-23
04022495166579Stimuplex®489436748943672016-09-23
04022495187826Stimuplex®489453948945392016-09-23
04046955665075Extension Set4906304906302021-02-08
04046964991257Extension Set4904864904862017-04-03
04046955270347IV Administration Set4905504905502019-02-22
04046955287475IV Administration Set4905744905742018-10-05
04046955203307IV Administration Set4905294905292018-06-15
04046964296734Extension Set4565224565222016-09-23
04046955874330INTROCAN SAFETY®4251610-024251610-022026-10-11
04046955765164IV Administration Set4906404906402026-09-27
04046955114559IV Administration Set4905014905012026-09-19
04046955862658Design Options®5522045522042026-08-17
04046955966233Design Options®5302095302092026-08-17
04046955966370Design Options®5703615703612026-08-17
04046961025153Prontosan®4006044006042026-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04046955966233Design Options®B. BRAUN MEDICAL INC.OFT2026-08-17
10198956530652CARDINAL HEALTHCardinal Health 200, LLCOFT2026-07-27
10198956468665CARDINAL HEALTHCardinal Health 200, LLCOFT2026-06-03
10193489437966Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-07-29
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