Model: MA101BK
Catalog: MA101BK
DI: 00841447116448
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Alternating Air Mattress & Pump - Black
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0bc270ea-a366-4485-8520-a6402e979691
Distribution Status:
In Commercial Distribution
DUNS Number:
076916246
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00841447116448
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47478
Name: Alternating-pressure bed mattress overlay system
Definition:
An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.
FDA Product Codes
FNM
Mattress, Air Flotation, Alternating Pressure