AccessGUDID - DEVICE: Argyle (00884521149796)

GUDID

Device Identifier (DI) Information

Brand Name: Argyle
Version or Model: 8888591024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8888591024
Company Name: Cardinal Health, Inc.

Primary DI Number: 00884521149796
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Aortic Perfusion Cannula,Angled Tip

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?
37696	Cerebral perfusion catheter	A sterile, flexible tube designed for retrograde cerebral perfusion with oxygenated cold blood. It is a two-lumen tube with several side holes and a balloon attached at its tip. The device is inserted into the internal jugular vein via a puncture in such a way that the holes remain in the vein so they can be used for cerebral perfusion even in the case of competent venous valves at the jugular-subclavian junction. It is then advanced until the inflation of the balloon at its tip occludes the drainage veins (superior vena cava and azygos vein). It is used for brain protection during profound hypothermic circulatory arrest during aortic surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: 47e45004-6502-4773-9b8e-986173dd91da
Public Version Date: February 15, 2019
Public Version Number: 5
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00884521063221	10	00884521149796		In Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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