AccessGUDID - DEVICE: EasyFlow Duo Cannula (00803622128073)

GUDID

Device Identifier (DI) Information

Brand Name: EasyFlow Duo Cannula
Version or Model: Duo Cannula
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIVANOVA USA, INC.

Primary DI Number: 00803622128073
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?
35565	Aorta cannula	A sterile, rigid or semi-rigid tube that is surgically inserted into the aorta, typically through the femoral artery and advanced until its distal tip is inside the abdominal aorta, to serve as a channel for the transport of fluid. It may be used for a variety of purposes, e. g, the injection or withdrawal of substances and/or blood, and commonly for external blood circulation during cardiopulmonary bypass procedures or as an outflow for ventricular assist systems. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.	Obsolete	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 [?]
K091542	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: efbd47fb-29e9-454a-ba30-0a25361df8f5
Public Version Date: August 15, 2018
Public Version Number: 4
DI Record Publish Date: September 17, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10803622128070	1	00803622128073		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

[?]

No Customer Contact currently defined

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