FDA.report

Design Options®

Primary DI
04046964808906
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
530165
Catalog number
530165
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

Related Records

Contact Domains

Product Codes

CodeName
OFTSpinal epidural anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964808906PrimaryGS10
04046964808890Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964808906040469648089064046964808906
04046964808890040469648088904046964808890

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
Handling Environment Temperature1 Degrees Celsius40 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

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04046964296710Extension Set4565214565212016-09-23
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04046964296697Extension Set4565204565202016-09-23
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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

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