DEVICE: VESCO (20813939024962)
Device Identifier (DI) Information
VESCO
70-0062-224
In Commercial Distribution
XERIDIEM MEDICAL DEVICES, INC.
70-0062-224
In Commercial Distribution
XERIDIEM MEDICAL DEVICES, INC.
24 Fr - Gastrostomy Tube - Dual ENFit Port (Tri-Funnel)
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
64461 | Enteral feeding noninvasive-component set |
A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.
|
Active | false |
63942 | Gastrostomy depth sizer |
A device intended to be used to measure the depth of a gastrointestinal stoma, from its opening to its terminus within the body, to help in the selection of an appropriately sized gastrostomy appliance (gastrostomy tube). It is typically in the form of a graduated catheter, intended to be inserted into the stoma, which may include an inflatable balloon at the distal end to secure its position after insertion. This is a single-use device.
|
Active | false |
35419 | Gastrostomy tube |
A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PIF | Gastrointestinal Tubes With Enteral Specific Connectors |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K171347 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ef86e0a8-6bc1-4f7b-9596-81a27aead16e
June 24, 2025
1
June 16, 2025
June 24, 2025
1
June 16, 2025
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
[?]
520-975-9508
maia.kirk@spectrumplastics.com
maia.kirk@spectrumplastics.com