AccessGUDID - DEVICE: Tendyne™ (05415067032027)

GUDID

Device Identifier (DI) Information

Brand Name: Tendyne™
Version or Model: TENDV-WT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TENDV-WT
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067032027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: 2 lb Weight

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:	No
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?
64590	Pressure monitor calibration weight	A mass of material of exact known weight intended to be used to calibrate the settings on a medical device pressure monitor. It may be used with a stand-alone pressure monitor or with a pressure monitor incorporated within a larger parent device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPU	Prosthesis, mitral valve, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 2.0000 Pound

Device Record Status

Public Device Record Key: 5c7f1aff-9e26-4cec-8bb9-496707260592
Public Version Date: June 06, 2025
Public Version Number: 1
DI Record Publish Date: May 29, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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