AccessGUDID - DEVICE: Argyle (20884527000170)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888257527
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8888257527
Company Name: Cardinal Health, Inc.

Primary DI Number: 20884527000170
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Suction Catheter with Mucus Trap,20 mL

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):	Yes
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?
63649	General-purpose surgical suction system, vacuum	An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	TRAP, STERILE SPECIMEN

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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter
Catheter Gauge: 10 French

Device Record Status

Public Device Record Key: 0cdb9a23-5f3a-4f2d-b231-f46d59d13855
Public Version Date: November 18, 2025
Public Version Number: 7
DI Record Publish Date: September 24, 2016