AccessGUDID - DEVICE: Argyle (10192253040371)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888160648
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8888160648
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10192253040371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Argyle Polyurethane Umbilical Vessel Catheter Triple Lumen 5 Fr/Ch (1.7 mm) x 9-8/10"" (25 cm) 18/21/21 G (1.3/0.8/0.8 mm) 0.32 mL, 0.19 mL, 0.19 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):	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?
10759	Umbilical catheter	A very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or triple lumen to enable additional concurrent functions such as vital sign monitoring and blood sampling (e.g., for blood gas analysis). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOS	CATHETER, UMBILICAL ARTERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Catheter Gauge: 5 French
Length: 9.8 Inch

Device Record Status

Public Device Record Key: 6a134ee7-9452-4127-9197-ad3cda96222c
Public Version Date: September 02, 2024
Public Version Number: 1
DI Record Publish Date: August 23, 2024