DEVICE: EndoVive Low Profile Replacement Button (08714729284079)

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Device Record History
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Device Identifier (DI) Information
EndoVive Low Profile Replacement Button
M00562840
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
08714729284079
GS1

1
021717889 *Terms of Use
Low Profile Replacement Gastrostomy Tube
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
11677 Enteral feeding kit, adult/paediatric, sterile
A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 8.0 mm Diameter
Device Size Text, specify: 3.4 cm Length
Device Size Text, specify: 24 F Diameter
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Device Record Status
51f27586-065d-40f6-83cd-a084bbbb444d
March 29, 2018
2
September 24, 2016
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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

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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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