FDA.reportPublic FDA data

CoreCare

Primary DI
00850091070020
Brand
CoreCare
Company
Corecare Products Inc.
Model
Exam Table Paper 18" x 225'
Published
2026-09-08
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
KMEBedding, Disposable, Medical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091070020PrimaryGS10
10850091070027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091070020008500910700208500910700200850091070020
1085009107002710850091070027

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table paperA non-sterile sheet made of paper intended to cover the surface of an examination/treatment table, or chair, during use to function as a barrier between the table top and the patient to maintain hygienic conditions. It is typically supplied in a roll designed to be mounted at one end of the table such that a new length of paper can be pulled down over the table top for each new patient. This is a single-use device.

Regulatory Flags#

DUNS number
134870424
Device count
12
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
true
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
00850091070006CoreCareExam Table Paper 21" 'x 225'2026-09-08
00850091070037CoreCareInsulin Syringe, double cap, 0.3ml, 30GX5/16'2026-09-11
00850091070051CoreCareInsulin Syringe, double cap, 1ml,30GX5/2026-09-11
00850091070068CoreCareInsulin Syringe, double cap, 0.5ml, 30GX5/16'2026-09-11
00850091070099CoreCareInsulin Syringe, double cap 1ml, 31GX5/16''2026-09-11
00850091070112CoreCareInsulin Syringe, double cap 0.5ml, 31GX5/162026-09-11
00850091070136CoreCareInsulin Syringe, double cap 0.3ml, 31GX5/12026-09-11
00850091070150CoreCareDisposable needle, 18GX1''2026-09-11
00850091070174CoreCareDisposable needle, 25GX1''2026-09-11
00850091070198CoreCareDisposable needle, 22GX1 1/2''(One and half inch2026-09-11
00850091070228CoreCareDisposable needle, 26GX5/8''2026-09-11
00850091070440CoreCareAlcohol Wipe 30x60mm2026-09-08
00850091070457CoreCareAlcohol Wipe 60x60mm2026-09-08
00850091070471CoreCareDisposable needle, 27Gx1 1/2'' (One and half inc2026-09-11
00850091070495CoreCareDisposable needle, 30GX1''2026-09-11
00850091070518CoreCareDisposable needle, 30GX1/2''2026-09-11
00850091070532CoreCare3ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070556CoreCare1ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070570CoreCare5ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070594CoreCare10 ml Luer-Lock Syringes W/O Needle2026-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086479296ValmaxSupply Line MedicalKME2026-10-19
10809160538937HalyardMEDICAL ACTION INDUSTRIES INC.KME2026-09-24
00850091070006CoreCareCorecare Products Inc.KME2026-09-08
00860015694799Prism Microclimate PadPrism Pacific Industries LLCKME2026-08-27
04260647540321TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
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
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 228Dynarex CorporationKME2026-07-31
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
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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