DEVICE: COMPOSURE MATTRESS ASSEMBLY (00850520008181)
Device Identifier (DI) Information
COMPOSURE MATTRESS ASSEMBLY
ASM100204
In Commercial Distribution
KREG MEDICAL INC.
ASM100204
In Commercial Distribution
KREG MEDICAL INC.
Hospital Bed Surface
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 63237 | Foam bed mattress |
A large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.
|
Active | false |
| 32180 | Antimicrobial bed mattress cover |
A device made of soft textile materials shaped to fit over a bed mattress, to protect the mattress and prevent cross-contamination, that is treated/impregnated with an antimicrobial substance to control bacterial and fungal growth on the fabric and reduce the levels of house dust mites (HDM) and their allergen-containing faecal droppings. The device can be laundered for cleaning. This is a reusable device.
|
Active | false |
| 37455 | Waterproof bed mattress cover, reusable |
A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered |
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
bdc77243-abc3-4896-9750-c073dc54ccff
October 22, 2018
1
September 21, 2018
October 22, 2018
1
September 21, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(866) 760-5734
kmiudiInfo@kreg.us
kmiudiInfo@kreg.us