FDA.reportPublic FDA data

Design Options®

Primary DI
04046955589364
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
530193
Catalog number
530193
Device description
SESK METHODIST HOSPITAL SPINAL EPIDURAL
Published
2020-04-24
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
04046955589364PrimaryGS10
04046955589357Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955589364040469555893644046955589364
04046955589357040469555893574046955589357

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
04046955900107Design Options®5301605301602026-11-03
04046964716263IV Administration Set4701554701552026-11-02
04046955350834SAFECAN™6132016132012020-03-06
04046955350896SAFECAN™6132046132042020-03-06
04046955764853SAFECAN™6134436134432023-05-04
04046955764877SAFECAN™6134446134442023-05-04
04046955764891SAFECAN™6134456134452023-05-04
04046955764914SAFECAN™6134466134462023-05-04
04046964326660Intradyn™6101456101452016-09-23
04046964326707Intradyn™6101466101462016-09-23
04046964330650Intradyn™6105596105592016-09-23
04046964330797Intradyn™6105766105762016-09-23
04046964330834Intradyn™6105776105772016-09-23
04046964331411Intradyn™6106466106462016-09-23
04046964331510Intradyn™6106506106502016-09-23
04046964331572Intradyn™6106526106522016-09-23
04046964331633Intradyn™6106546106542016-09-23
04046964333415Intradyn™6110996110992016-09-23
04046964717154SAFECAN™6131086131082016-09-23
04046964717178SAFECAN™6131096131092016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955900107Design Options®B. BRAUN MEDICAL INC.OFT2026-11-03
10198956599208CARDINAL HEALTHCardinal Health 200, LLCOFT2026-10-15
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
10193489211931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489213485Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214369Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489214468Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215373Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489215878Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489216233Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489412222Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489413717Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414288Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414745Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489414752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489417821Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489418057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489419092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422313Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422344Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489422443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489423396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425277Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489425284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489429909Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432008Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08
10193489432022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2023-06-08