DEVICE: Ensemble™ (00643169588448)

Device Identifier (DI) Information

Ensemble™
NU1020
Not in Commercial Distribution

MEDTRONIC, INC.
00643169588448
GS1
May 13, 2016
1
006261481 *Terms of Use
DELIV SYS NU1020 ENSEMBLE US
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60247 Pulmonary transcatheter heart valve bioprosthesis
An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NPV Pulmonary valve prosthesis percutaneously delivered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P140017 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Outer Balloon Size 20 MM
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Device Record Status

5c403426-9973-408f-aa08-06009e59303b
February 05, 2021
5
February 24, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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