FDA.reportPublic FDA data

HCS

Primary DI
10810132043007
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
81801
Device description
Transfer Repositioning Sheet w/Straps, 35" x 55"
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810132043007PackageGS112In Commercial Distribution
00810132043000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204300710810132043007
00810132043000008101320430008101320430000810132043000

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer/turning sheet, single-useA manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080220245
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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00689281037419Wave Grab Bar, 18" Length, Left and Right, Polished Chrome (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281038065Wave Grab Bar, 1.25x18" Length, Matte BlackHealthcraft Products Inc.IKX2026-10-13
00689281038072Wave Grab Bar, 1.25x18" Length, Brushed StainlessHealthcraft Products Inc.IKX2026-10-13
00689281038089Wave Grab Bar, 1.25x18" Length, Brushed GoldHealthcraft Products Inc.IKX2026-10-13
00689281038096Wave Grab Bar, 1.25x18" Length, Polished ChromeHealthcraft Products Inc.IKX2026-10-13
00689281038348Wave Grab Bar, 18" Length, Left and Right, Brushed Gold (2 pk)Healthcraft Products Inc.IKX2026-10-13
00689281039413Wave Grab Bar, 1.25x18" Length, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-10-13
00810226442962ViveVIVE HEALTH LLCIKX2026-10-12
00689281039604Easy Mount™ Grab Bar, Modular L-Shape, 1.25x16x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039611Easy Mount™ Grab Bar, Modular L-Shape, 1.25x24x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039628Easy Mount™ Grab Bar, Modular L-Shape, 1.25x30x30", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008105Easy Mount™ Grab Bar, 1.25x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008112Easy Mount™ Grab Bar, 1.25x32", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008129Easy Mount™ Grab Bar, 1.25x36", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008136Easy Mount™ Grab Bar, 1.25x42", KnurledHealthcraft Products Inc.IKX2026-09-30