DEVICE: UNDERPAD QUILTED IBEX (00634916111057)
Device Identifier (DI) Information
UNDERPAD QUILTED IBEX
59761900
Not in Commercial Distribution
59761900
STANDARD TEXTILE CO., INC.
59761900
Not in Commercial Distribution
59761900
STANDARD TEXTILE CO., INC.
UNDERPAD QUILTED IBEX KAUM POLY 33X36 RM (98 7798) USE: 59748100
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
66117 | Absorbent underpad, non-antimicrobial, reusable |
A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMW | Cover, Mattress (Medical Purposes) |
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
f92a4db4-148d-481b-8b6e-420ea8ba8e58
December 30, 2024
5
January 29, 2018
December 30, 2024
5
January 29, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10634916111054
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-999-0400
GUDID@standardtextile.com
GUDID@standardtextile.com