DEVICE: Halyard (10680651287257)
Device Identifier (DI) Information
Halyard
28725
In Commercial Distribution
7120-14-1.0
Avanos Medical, Inc.
28725
In Commercial Distribution
7120-14-1.0
Avanos Medical, Inc.
HALYARD* MIC-KEY* SF Low Profile Gastrostomy Feeding Tube
Device Characteristics
MR Conditional | |
No | |
Yes | |
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? |
---|---|---|---|---|
38565 | Gastrostomy button |
A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K043114 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 14 French |
Device Record Status
b4c48ccb-5553-4b04-ab07-520e8fcc6274
October 07, 2019
2
February 01, 2019
October 07, 2019
2
February 01, 2019
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(844)425-9273
PIQ@hyh.com
PIQ@hyh.com