AccessGUDID - DEVICE: PLEUR-EVAC (34026704631729)

GUDID

Device Identifier (DI) Information

Brand Name: PLEUR-EVAC
Version or Model: IPN028490
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S-1200-08LF
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 34026704631729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 34026704607366

Device Description: PLEUR-EVAC SAHARA DRY SUCTION/SEAL LATEX FREE W/AUTOTRANSFUSION

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:	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
KDQ	BOTTLE, COLLECTION, VACUUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962856	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
Width: 17 Inch
Depth: 3.5 Inch
Total Volume: 4350 Milliliter
Length: 10.5 Inch

Device Record Status

Public Device Record Key: 460b237f-c731-43d2-ba85-95a09f623582
Public Version Date: May 02, 2024
Public Version Number: 3
DI Record Publish Date: July 09, 2019