DEVICE: Design Options® (04046964315879)
Device Identifier (DI) Information
Design Options®
555482
In Commercial Distribution
555482
B. BRAUN MEDICAL INC.
555482
In Commercial Distribution
555482
B. BRAUN MEDICAL INC.
Combined Spinal/Epidural Tray
Device Characteristics
MR Unsafe | |
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 |
---|---|
Epidural/intrathecal anaesthesia kit | A collection of sterile devices designed to deliver an analgesic or anaesthetic agent into the epidural and subarachnoid (intrathecal) spaces around the spinal cord for pain management. It typically includes a procedural needle(s), syringe, catheter(s), and filter(s), but does not include medication. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OFT | Spinal epidural anesthesia kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 1 and 40 Degrees Celsius |
Storage Environment Temperature: between 20 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Gauge epidural needle : 17 |
Device Size Text, specify: Gauge (Catheter) : 19 |
Device Size Text, specify: Gauge spinal needle : 25 |
Device Record Status
c3596760-1bab-4201-96df-182a0ab21938
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046964315855
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
BBMUS_Service.EmailOrders@bbraun.com