AccessGUDID - DEVICE: Argyle (10884527019380)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888271106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8888271106
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527019380
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: 5-in-1 Bubble Connector,Vinyl

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?
42988	Low-pressure tubing connector, reusable	A device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.	Obsolete	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: ;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Greatest Diameter,3/16 - 7/16,Inch;

Device Record Status

Public Device Record Key: fdcc0dfd-bf29-4abf-8c45-e1f964b40839
Public Version Date: July 03, 2023
Public Version Number: 8
DI Record Publish Date: September 24, 2016