FDA.reportPublic FDA data

DALTON BARIATRIC LOW AIR LOSS MATTRESS SYSTEM

Primary DI
00815027011812
Brand
DALTON BARIATRIC LOW AIR LOSS MATTRESS SYSTEM
Company
DALTON MEDICAL CORPORATION
Model
PM-NEOPRO-48
Device description
BARIATRIC AIR MATTRESS SYSTEM WITH LOW AIR LOSS, WT. LIMIT 900 LBS.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815027011812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815027011812008150270118128150270118120815027011812

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled bed mattress overlayA static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, 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. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874709348
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDBED42002026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDBED48002026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDBED54002026-02-27
00815027011867DALTON ROLLATOR AR-8411KDAR2025-10-28
00815027011881DALTON ROLLATOR AR-8411KDBL2025-10-28
00815027012871DALTON LOW AIR LOSS MATTRESS SYSTEMPM-XCEL5000TURN2025-10-28
00815027012888DALTON ROLLATOR AR-56430KDAR2025-10-28
00815027012703DALTON TRANSFER BENCHTB-5058-12025-09-18
00815027012741DALTON QUAD CANEA-QC4011SBK-42025-09-18
00815027012758DALTON TRANSFER BENCHTB-5006KDHD-22025-09-18
00815027012765DALTON SHOWER BENCHBS-5013A-22025-09-18
00815027012772DALTON YOUTH WALKERA-WA6107W-22025-09-18
00815027012789DALTON WALKER A-WA6006HD-22025-09-18
00815027012796DALTON WALKER A-WA6005HEM2025-09-18
00815027012819DALTON WALKER PLATFORMA-WPA6401-22025-09-18
00815027012826DALTON COMMODE CHAIRCOM-DA500-22025-09-18
00815027012833DALTON COMMODE CHAIRCOM-DA300-22025-09-18
00815027012840DALTON TOILET SEATBS-30271G-12025-09-18
00815027012864DALTON SHOWER BENCHBS-5004-42025-09-18
00815027012734DALTON OVERBED TABLEB-T3616ABS2025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28