DEVICE: Epimed (00818788021137)
Device Identifier (DI) Information
Epimed
156-2124
In Commercial Distribution
156-2124
EPIMED INTERNATIONAL, INC
156-2124
In Commercial Distribution
156-2124
EPIMED INTERNATIONAL, INC
Versa-Kath® 21g x 24"
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
34842 | Epidural anaesthesia set, non-medicated |
A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BSO | CATHETER, CONDUCTION, ANESTHETIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K954584 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 2.4 French |
Device Size Text, specify: 24" |
Length: 24 Inch |
Device Size Text, specify: 21g |
Device Record Status
134dbbc5-5719-4e21-a17f-22a4f9355201
August 07, 2023
6
October 20, 2017
August 07, 2023
6
October 20, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10818788021134 | 10 | 00818788021137 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)866-3342
customerservice@epimed.com
customerservice@epimed.com