FDA.reportPublic FDA data

ICP

Primary DI
00813360021628
Brand
ICP
Company
ICP MEDICAL, LLC
Model
1
Catalog number
ICP-9001GUR
Device description
Stretcher Sheet, White, 96x37
Published
2020-07-13
Public version status
Update
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
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813360021625PackageGS110In Commercial Distribution
20813360021622PackageGS110In Commercial Distribution
00813360021628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002162510813360021625
2081336002162220813360021622
00813360021628008133600216288133600216280813360021628

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof bed mattress cover, reusableA device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Width0

Regulatory Flags#

DUNS number
078780963
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
00688162000764Protexter1ICP-83502026-08-05
00688162000023ProtexerICP-SCNSICP-SCNS00012025-08-19
00688162000047ProtexerICP-BCNCICP-BCNC00032022-10-31
00688162000054ProtexerICP-CPPSB 21"ICP-CPPSB00212022-10-31
00688162000467ICP2ICP-9001GUR2023-10-05
00688162000511Protexter1ICP-8150FC-2XL2025-08-12
00688162000665ProtexerPR-Shoe CoversPR-SCGT012026-04-27
00688162000672ProtexerPR-Shoe CoversPR-SCGT022026-04-27
00688162124002ProtexerICP-CPXP 24ICP-CPXP242022-10-31
00688162381504ProtexerICP-BCNSICP-BCNS00022022-10-31
00688162400007ProtexerICP-CPPSB 24"ICP-CPPSB00242022-10-31
00688162800005ProtexerICP-CPPSB 28"ICP-CPPSB00282022-10-31
00813360021369ProtexerICP-8200ICP-82002022-01-17
00813360021376ProtexerICP-8250ICP-82502022-01-17
00813360021390ProtexerICP-3845ICP-38452022-02-03
00813360021468ProtexerICP-Lab CoatsICP-9054LC2025-08-08
00813360021475ProtexerICP-Lab CoatsICP-9055LC2025-08-15
00813360021505Protexter181502020-07-09
00813360021512ProtexerPR-BCBPR-BCB5002025-08-19
00813360021543ProtexerICP-5050YFCICP-5050YFC2022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196888US MATT PAD-UNI-CONNECT-18MO-10X15CURBELL MEDICAL PRODUCTS, INC.FMW2026-07-23
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PCURBELL MEDICAL PRODUCTS, INC.FMW2026-04-08
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMW2026-01-15
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850056748315FORWARD APLS Surgery SoakerINTEGRATED MEDCRAFT LLCFMW2025-11-06