AccessGUDID - DEVICE: Smart Connector (00803622124983)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Connector
Version or Model: Smart Connector
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIVANOVA USA, INC.

Primary DI Number: 00803622124983
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?
35338	Arteriovenous/external shunt connector	A device designed to connect an arteriovenous (AV) or external shunt to the tubing of an extracorporeal blood circuit, typically part of a haemodialysis system, for withdrawal/infusion of blood. It is typically made of plastic or metal and Y-shaped, allowing alternate withdrawal and infusion of blood. The device is intended to perform haemodialysis using the single-needle/single-lumen needle technique. 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 [?]
K981613	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: b02a9948-008b-4751-bfa5-5e2fb19594f5
Public Version Date: August 15, 2018
Public Version Number: 4
DI Record Publish Date: May 19, 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
10803622124980	10	00803622124983		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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