FDA.reportPublic FDA data

Design Options®

Primary DI
04046964989742
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
552117
Catalog number
552117
Device description
Continuous Epidural Tray
Published
2016-10-24
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
OGEEpidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964989742PrimaryGS10
04046964989735Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964989742040469649897424046964989742
04046964989735040469649897354046964989735

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
04046964315954Design Options®5554845554842016-09-23
04046955582969Perfusor®8713330-998713330-992026-06-07
04046955862634Design Options®5522035522032026-06-01
04046955966264Design Options®5522075522072026-06-01
04046964177347Perifix®3320873320872016-09-23
04046964178900Perifix®3322643322642016-09-23
04046955672370Design Options®5606805606802026-05-24
04046955900268Design Options®5517695517692026-05-14
04046964308024Design Options®5517695517692016-09-23
04045928020392Design Options®5521235521232026-05-11
04045928020699Design Options®5521795521792026-05-11
04046955803125Clik-Fix®LLS-1021BLLS-1021B2023-01-06
04046955803163Clik-Fix®LLS-1024BLLS-1024B2023-01-06
04046955803194Clik-Fix®NPS-1006BNPS-1006B2022-12-22
04046955803231Clik-Fix®LLSK-1024BLLSK-1024B2023-01-06
04046955803255Clik-Fix®PCS-1011BPCS-1011B2022-12-22
04046955803286Clik-Fix®WCS-1000BWCS-1000B2023-03-13
04046955803316Clik-Fix®WCS-1003BWCS-1003B2023-03-06
04046955803347Clik-Fix®WCS-1006BWCS-1006B2023-01-06
04046955840878Clik-Fix®ECS-1000BECS-1000B2025-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956483255CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-03
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04046955966264Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
10198956316096CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-01
10197106012888CARDINAL HEALTHCardinal Health 200, LLCOGE2023-07-12
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10195594853952CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-20
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10195594886318CARDINAL HEALTHCardinal Health 200, LLCOGE2022-10-11