DEVICE: Flex-Neck® (00884450305997)

Device Identifier (DI) Information

Flex-Neck®
00884450305997
In Commercial Distribution
CE-1400/B
Merit Medical Systems, Inc.
00884450305997
GS1

1
184763290 *Terms of Use
No description.
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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?
35944 Peritoneal dialysis catheter adaptor, single-use
A connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FJS Catheter, peritoneal, long-term indwelling
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
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
No Device Sizes
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Device Record Status

5da9725c-105f-4698-bcaa-4f1d4d37d833
April 03, 2023
1
March 25, 2023
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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
10884450305994 1 00884450305997 In Commercial Distribution
20884450305991 60 10884450305994 In Commercial Distribution
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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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