AccessGUDID - DEVICE: E-CATH TSUI (04048223065693)

GUDID

Device Identifier (DI) Information

Brand Name: E-CATH TSUI
Version or Model: 251185-40E
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 251185-40E
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223065693
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223037277

Device Description: 251185-40E

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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 10 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8b8a3f2-1e68-45ad-8237-9ba7c1b7b000
Public Version Date: June 17, 2025
Public Version Number: 3
DI Record Publish Date: April 02, 2021