AccessGUDID - DEVICE: EpiLong Soft Cath (04048223073896)

GUDID

Device Identifier (DI) Information

Brand Name: EpiLong Soft Cath
Version or Model: 041151-37P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 041151-37P
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223073896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: EpiLong Soft Cath 19G x 90cm with closed tip and 6 lateral eyes

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64374	Epidural anaesthesia stand-alone catheter	A flexible tube, supplied in isolation of other devices, intended to be percutaneously introduced into the epidural space for the delivery of an anaesthetic/analgesic agent; it is not coated with an antimicrobial agent. It is intended to be introduced using an epidural needle, however neither the needle nor other procedural assistive devices are included (i.e., the catheter is sold alone and this is not an epidural set). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 90.0 Centimeter
Needle Gauge: 19.0 Gauge

Device Record Status

Public Device Record Key: 83fcd6c9-559e-4c8c-8747-15dd6629fbb0
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025