AccessGUDID - DEVICE: Argyle (10884527018451)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 155657
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 155657
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527018451
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 50
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Sims Irrigating Nozzle

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:	No
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?
64085	Non-ISO80369-standardized small-bore linear connector, reusable	A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with a connection at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a reusable 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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: b22b426c-1c78-401c-af53-e849e19b5dd8
Public Version Date: March 12, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016