DEVICE: Combined Spinal & Epidural (04046964179327)

Download: XML | JSON

Device Identifier (DI) Information

Combined Spinal & Epidural
333197
333197
B. BRAUN MEDICAL INC.
04046964179327
GS1
10
PERIFIX® 17 Ga. x 3½ in. Tuohy, PENCAN® 27 Ga. x 5 in. Pencil-Point Spinal Needle, PERIFIX® FX 19 Ga. Springwound Open Tip, 5 mL Glass Luer Slip LOR Tray (Kit)
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OFT Spinal epidural anesthesia kit
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Handling Environment Temperature: between 1 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Gauge spinal needle : 27
Device Size Text, specify: Gauge epidural needle : 17
Device Size Text, specify: Gauge (Catheter) : 19
CLOSE

Device Status

In Commercial Distribution
September 23, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 04046964179310 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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