FDA.reportPublic FDA data

HCS

Primary DI
00810132043369
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
81721
Device description
"Underpad, Drypad X-Large, 40""x80"", White, Bariatric, Air-permeable, max absorbency"
Published
2024-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810132043366PackageGS18In Commercial Distribution
00810132043369PrimaryGS10
20810132043363Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204336610810132043366
00810132043369008101320433698101320433690810132043369
2081013204336320810132043363

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobial, single-useA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Regulatory Flags#

DUNS number
080220245
Device count
5
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
20810132043721HCS6606W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04260647540345TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
04260647540369TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
00199972000535CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000559CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
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00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19