DEVICE: Design Options® (04046964321375)

Device Identifier (DI) Information

Design Options®
560621
In Commercial Distribution
560621
B. BRAUN MEDICAL INC.
04046964321375
GS1

10
002397347 *Terms of Use
Spinal Tray
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Intrathecal anaesthesia kit A collection of sterile devices and supplies used to deliver an analgesic or anaesthetic agent to the subarachnoid (intrathecal) space around the spinal cord. It is used for pain management and typically consists of a procedural needle, syringe, catheter, and a filter, but does not include medication. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
OFU Spinal anesthesia kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8253996d-c5f9-4907-9f46-a105f40287f8
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04046964321368 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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