AccessGUDID - DEVICE: Contegra® (00613994600301)

GUDID

Device Identifier (DI) Information

Brand Name: Contegra®
Version or Model: 200H18
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994600301
Issuing Agency: GS1
Commercial Distribution End Date: October 05, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: CNDT 200H18 CONTEGRA UNSUPP HDE PS

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60337	Pulmonary open-surgery heart valve bioprosthesis	A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair/replace a dysfunctional pulmonary heart valve, or to replace a pulmonary valve in patients undergoing a pulmonary autograft (Ross) procedure. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MWH	pulmonic valved conduit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H020003	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Valve Size 18 MM

Device Record Status

Public Device Record Key: 18007994-fca1-4b6b-957a-a9f8bf3bf086
Public Version Date: May 22, 2025
Public Version Number: 6
DI Record Publish Date: September 23, 2014

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

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES