AccessGUDID - DEVICE: E-Cath® II Plus Tsui® (04048223122020)

GUDID

Device Identifier (DI) Information

Brand Name: E-Cath® II Plus Tsui®
Version or Model: 311285-41E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 311285-41E
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223122020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: E-Cath® II Plus Tsui® SonoPlex® Stim cannula 21G with indwelling catheter 18G x 80mm

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?
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). 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 [?]
K152952	000

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: 80.0 Millimeter
Needle Gauge: 18.0 Gauge

Device Record Status

Public Device Record Key: 4a716c12-c659-4d45-853f-42eb277bf347
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025