DEVICE: Kangaroo (10884521011663)
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Device Identifier (DI) Information
Kangaroo
8884742019
Not in Commercial Distribution
8884742019
Cardinal Health, Inc.
8884742019
Not in Commercial Distribution
8884742019
Cardinal Health, Inc.
Skin Level Cage Gastrostomy Kit
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? |
|---|---|---|---|---|
| 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 [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Catheter Gauge: 20 French |
| Length: 1.5 Centimeter |
Device Record Status
c78e8404-b37e-44ec-ba08-d503007bec76
August 18, 2023
9
September 24, 2016
August 18, 2023
9
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20884521011660 | 30 | 10884521011663 | 2023-08-18 | Not in Commercial Distribution | CASE |
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
[?]
No Customer Contact currently defined