FDA.reportPublic FDA data

Endurance Standard Alternating Pressure Bubble Pad

Primary DI
10754756388000
Brand
Endurance Standard Alternating Pressure Bubble Pad
Company
ESSENTIAL MEDICAL SUPPLY INC
Model
D8800
Published
2017-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
10754756388000PackageGS110In Commercial Distribution
00754756388003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075475638800010754756388000
00754756388003007547563880037547563880030754756388003

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
407-770-0710michael.hoepner@essentialmedicalsupply.com

Regulatory Flags#

DUNS number
189331325
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754756740009Essential TENS SystemS1000 2017-04-11
00754756740016TENS Electrode SetS1000E2017-04-11
00754756750008Essential Digital TENS SystemS20002017-04-11
10754756740006Essential TENS SystemS1000 2017-04-11
20754756740010TENS Electrode SetS1000E2017-04-11
10754756750005Essential Digital TENS SystemS20002017-04-11
00754756388003Endurance Standard Alternating Pressure Bubble PadD88002017-11-07
00754756390013Endurance Deluxe Alternating Pressure Pump & Pad ComboD9000C2017-11-07
00754756380007Endurance Standard Alternating Pressure PumpD80002017-11-07
00754756380014Endurance Standard Alternating Pressure Pump & Pad ComboD8000C 2017-11-07
00754756388010Endurance Standard Alternating Pressure Bubble Pad w/FlapsD8800EX2017-11-07
00754756390006Endurance Deluxe Alternating Pressure PumpD90002017-11-07
10754756390010Endurance Deluxe Alternating Pressure Pump & Pad ComboD9000C2017-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.FNM2026-06-09
00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-4 D3XKAP MEDICALFNM2026-05-29
00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
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
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