DEVICE: Design Options® (04046964306105)
Device Identifier (DI) Information
Design Options®
530149
In Commercial Distribution
530149
B. BRAUN MEDICAL INC.
530149
In Commercial Distribution
530149
B. BRAUN MEDICAL INC.
Combined Spinal/Epidural Tray
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46308 | Epidural/intrathecal anaesthesia set, non-medicated |
A 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.
|
Active | false |
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 Record Status
9b87d42d-f98d-4152-9951-12c55312b2d1
June 15, 2020
5
September 23, 2016
June 15, 2020
5
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:
04046964306099
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