DEVICE: Avaline Medical NJ LLC (00650415209194)
Device Identifier (DI) Information
Avaline Medical NJ LLC
ZRUP3654Rx3+st
Not in Commercial Distribution
ZRUP3654Rx3+st
Avaline Medical NJ Limited Liability Company
ZRUP3654Rx3+st
Not in Commercial Distribution
ZRUP3654Rx3+st
Avaline Medical NJ Limited Liability Company
Washable Underpads 36"x54" x3
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
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 |
---|---|
EYQ | GARMENT, PROTECTIVE, FOR INCONTINENCE |
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
4d6bbfbf-0289-4307-b465-3d12ece4d987
June 20, 2023
3
March 23, 2022
June 20, 2023
3
March 23, 2022
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:
00810077213193
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(732)813-7799
204
jstein@avalinemedical.com
jstein@avalinemedical.com