AccessGUDID - DEVICE: Argyle (10884527019724)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888301739
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8888301739
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527019724
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 Tubing,Molded Connectors

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?
16779	Suction/irrigation tubing, single-use	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAZ	TUBING, NONINVASIVE

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: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.28125 Inch
Length: 20 Feet

Device Record Status

Public Device Record Key: f4b4acb7-0238-4080-966a-da383c37d3c1
Public Version Date: November 22, 2023
Public Version Number: 10
DI Record Publish Date: September 24, 2016