DEVICE: PUGGLE™ G-Tube (00704411007305)
Device Identifier (DI) Information
PUGGLE™ G-Tube
1
Not in Commercial Distribution
PLG18-20
AMSINO INTERNATIONAL, INC.
1
Not in Commercial Distribution
PLG18-20
AMSINO INTERNATIONAL, INC.
PUGGLE™ G-Tube
18 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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? |
|---|---|---|---|---|
| 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 |
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 |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
31483057-45d4-4ce3-8009-5078e514ca76
September 20, 2018
2
May 10, 2018
September 20, 2018
2
May 10, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 30704411007306 | 1 | 40704411007303 | 2018-09-20 | Not in Commercial Distribution | box |
| 40704411007303 | 20 | 00704411007305 | 2018-09-20 | 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