AccessGUDID - DEVICE: Centesis Procedure Kit (00886333220731)

GUDID

Device Identifier (DI) Information

Brand Name: Centesis Procedure Kit
Version or Model: A4341BSDF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A4341BSDF
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333220731
Issuing Agency: GS1
Commercial Distribution End Date: December 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Centesis Procedure Kit Drug Free with Safety Devices and Thoracentesis Catheter with 14ga Needle

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJT	Aspiration Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 478cd9f8-4667-483b-a038-ee967f6a69f8
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: July 20, 2022