AccessGUDID - DEVICE: NA (05415067042316)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: LT100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LT100
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067042316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use
Previous DI: 05415067004772

Device Description: Mechanical Heart Valve Leaflet Tester

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?
47469	Heart valve prosthesis tester, single-use	A sterile, pen-like device intended to be used to manually manipulate a heart valve prosthesis to perform an assessment of the valvular prosthesis (e.g., its ability to open and close) prior to implantation and/or when in situ. It typically has a handle made of plastic and a soft tip (e.g., made of rubber) to prevent damage of the valvular prosthesis. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXN	PROBE, TEST, HEART-VALVE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9fde485c-a7a1-4f63-8495-26f2e7b19786
Public Version Date: May 29, 2023
Public Version Number: 1
DI Record Publish Date: May 19, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
15415067042313	20	05415067042316		In Commercial Distribution

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(855)478-5833
Email: customerservice@sjm.com

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