Device
303-M803508HS2FB-BIL oneNEST M is a powered mattress 80'' x 35'' 2 ways. It can be used with or without control unit.
Manufacturer
Umano Medical Inc
Umano Medical Inc
Model: 303-M803508HS2FB-BIL
DI: 00670482001019
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
303-M803508HS2FB-BIL oneNEST M is a powered mattress 80'' x 35'' 2 ways. It can be used with or without control unit.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
63a30703-a6c4-4475-b452-a06286a9fe36
Distribution Status:
In Commercial Distribution
DUNS Number:
249675476
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10670482001016
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00670482001019
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00670482001019
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63641
Name: Alternating-pressure bed mattress
Definition:
A mattress-like device consisting of an arrangement of alternating-pressure air cells 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 is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat.
FDA Product Codes
IOQ
Bed, Flotation Therapy, Powered