DEVICE: Espocan® (04046964179242)
Device Identifier (DI) Information
Espocan®
333182
In Commercial Distribution
333182
B. BRAUN MEDICAL INC.
333182
In Commercial Distribution
333182
B. BRAUN MEDICAL INC.
ESPOCAN® 18 Ga. x 3-1/2 in. Tuohy, SPINOCAN® 27 Ga. x 5 in. Quincke-Bevel Spinal Needle, PERIFIX® 20 Ga. Closed Tip, 5 mL Glass Luer Lock LOR Tray (Kit)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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. 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 : 18 |
Device Size Text, specify: Gauge (Catheter) : 20 |
Device Size Text, specify: Gauge spinal needle : 27 |
Device Record Status
e82ac5c8-fbd6-4628-8b2d-a2f3ebbb1ab0
February 17, 2021
6
September 23, 2016
February 17, 2021
6
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:
04046964179235
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