FDA.reportPublic FDA data

Curaplex®

Primary DI
00810094577506
Brand
Curaplex®
Company
BOUND TREE MEDICAL, LLC
Model
3271-63401
Catalog number
3271-63401
Device description
"Curaplex Regular Cot Sheet, Light Blue, Elastic Ends, 84"" x 34"""
Published
2024-11-30
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
00810094577506PrimaryGS10
00810094578077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094577506008100945775068100945775060810094577506
00810094578077008100945780778100945780770810094578077

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed sheet, single-useA large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Regulatory Flags#

DUNS number
070556204
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094575809Curaplex680152-KIT680152-KIT2023-04-30
00815277028059Curaplex8600-ATFMLOK2016-12-14
00815277029377Curaplex680150-KIT680150-KIT2018-12-15
01999720000003Curaplex Advanced Hemostatic Gauze4in x 4in(10cm x 10cm)CAHG-4X42025-11-25
01999720000027Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-11-25
01999720000041Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-11-25
01999720000065Curaplex®8600-015558600-015552025-11-13
01999720000263Curaplex670070-KIT670070-KIT2025-11-25
00810071638619CURAPLEXS1137301-S11372023-03-30
00817617023052Curaplex3141-910103141-910102017-09-04
00817617023069Curaplex3141-910123141-910122017-09-04
00817617023083Curaplex3141-910143141-910142017-09-04
00817617023335Curaplex36111361112017-09-04
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08