AccessGUDID - DEVICE: E-Cath acc. Tsui (14048223025618)

GUDID

Device Identifier (DI) Information

Brand Name: E-Cath acc. Tsui
Version or Model: 201285-40E
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 201285-40E
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223025618
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: E-Cath acc. Tsui SonoPlex Stim cannula 21G x 68mm indwelling catheter 18G x 51mm

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6122018b-2dc0-4072-9535-d1b38e2724b0
Public Version Date: December 31, 2019
Public Version Number: 6
DI Record Publish Date: August 31, 2016