AccessGUDID - DEVICE: Cardiopulmonary bypass cannula vent plug (00803622103353)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiopulmonary bypass cannula vent plug
Version or Model: AX-xxxxx
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIVANOVA USA, INC.

Primary DI Number: 00803622103353
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080914995 *Terms of Use

Device Description: No description.

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?
61661	Cardiopulmonary bypass system tubing connector	A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K833322	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 018060da-199d-42e1-8103-c2080ed4b136
Public Version Date: August 15, 2018
Public Version Number: 4
DI Record Publish Date: July 16, 2015