AccessGUDID - DEVICE: PLEUR-EVAC (14026704911865)

GUDID

Device Identifier (DI) Information

Brand Name: PLEUR-EVAC
Version or Model: IPN927558
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A-4301-08LF
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704911865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704921833

Device Description: PLEUR-EVAC PNEUMONECTOMY LATEX FREE

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?
63652	Thoracic suction collection container	A device intended to be connected between a thoracic drainage catheter (not included) and a suction wall outlet, to collect fluids (e.g., blood), secretions and/or air during controlled aspiration of the pleural cavity and/or mediastinum. The device typically incorporates three graduated chambers, designed for fluid collection, water seal, and suction control, and a suction regulator, air leak indicator, and connection tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAC	Apparatus, autotransfusion

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
Depth: 2.5 Inch
Width: 13 Inch
Height: 18 Inch
Device Size Text, specify: Pneumonectomy Drain

Device Record Status

Public Device Record Key: 96e92b96-6d68-401d-b2ef-e04ab2194b03
Public Version Date: May 07, 2025
Public Version Number: 1
DI Record Publish Date: April 29, 2025