DEVICE: Decompression Tube (00842071104177)

Device Identifier (DI) Information

Decompression Tube
E3-2444
Not in Commercial Distribution
E3-2444, 3-2444
APPLIED MEDICAL TECHNOLOGY, INC.
00842071104177
GS1
June 30, 2023
1
038101861 *Terms of Use
24F x 4.4 cm Decompression Tube (Pouched)
CLOSE

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?
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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KGC Tube, Gastro-Enterostomy
KNT Tubes, Gastrointestinal (And Accessories)
CLOSE

FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 24 French
Length: 4.4 Centimeter
CLOSE

Device Record Status

9abc50b6-98ce-4527-809a-a1a52cfc3f99
July 03, 2023
5
August 31, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00842071106317 10 00842071104177 2023-06-30 Not in Commercial Distribution Box (3-2444)
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(440) 717-4000
cs@appliedmedical.net
CLOSE