Device
oneNEST M is a powered mattress 84''X35'' 2 ways. It can be used with or without control unit
Manufacturer
Umano Medical Inc
Model: 303-M843508HS2FB-BIL DI: 00670482001026 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
oneNEST M is a powered mattress 84''X35'' 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: 4be081be-8309-462e-a1ce-2aa52ce86d63
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: 10670482001023
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 1
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00670482001026
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00670482001026
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