FDA.reportPublic FDA data

Curaplex®

Primary DI
00810094579920
Brand
Curaplex®
Company
BOUND TREE MEDICAL, LLC
Model
SHVENT02-25-KIT
Catalog number
SHVENT02-25-KIT
Device description
Curaplex HeroVent Oxygen Kit
Published
2025-09-24
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
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094579937PackageGS120In Commercial Distribution
00810094579920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094579937008100945799378100945799370810094579937
00810094579920008100945799208100945799200810094579920

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration kitA collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Regulatory Flags#

DUNS number
070556204
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817617020389Curaplex680154-KIT680154-KIT2016-12-14
00810071637285Curaplex301-P3050301-P3050EA2022-12-30
00810071637292CuraplexP3052EA301-P3052EA2022-12-30
00810071637308Curaplex301-P3054301-P3054EA2022-12-30
00199972000436Curaplex8600-01565-KIT8600-01565-KIT2026-08-15
00199972000443Curaplex670283-KIT670283-KIT2026-08-15
00199972000450Curaplex670284-KIT670284-KIT2026-08-15
00199972000467Curaplex8600-01567-KIT8600-01567-KIT2026-08-15
00199972000474Curaplex8600-01558-KIT8600-01558-KIT2026-08-15
00199972000528CuraplexSIVBDIO02-26-KITSIVBDIO02-26-KIT2026-08-15
00199972000535Curaplex670289-KIT670289-KIT2026-08-15
00199972000559Curaplex670290-KIT670290-KIT2026-08-15
00199972000573Curaplex670291-KIT670291-KIT2026-08-15
00810094578053Curaplex®SIVBDIO01-24-KITSIVBDIO01-24-KIT2026-07-30
00199972000504Curaplex8600-015668600-015662026-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
00848530108809Ventilator accessorySunset Healthcare Solutions, Inc.CAI2026-04-27
10889483584705Vital Signs™AIRLIFECAI2025-03-06
10889483591666Vital Signs™AIRLIFECAI2025-02-18
10889483591925Vital Signs™AIRLIFECAI2025-02-18
10889483591987Vital Signs™AIRLIFECAI2025-02-18
10889483592113Vital Signs™AIRLIFECAI2025-02-18
10889483592496Vital Signs™AIRLIFECAI2025-02-18
10889483592656Vital Signs™AIRLIFECAI2025-02-18
10889483593448Vital Signs™AIRLIFECAI2025-02-18
10889483593561Vital Signs™AIRLIFECAI2025-02-18
10889483593660Vital Signs™AIRLIFECAI2025-02-18
10889483593752Vital Signs™AIRLIFECAI2025-02-18
10889483585627Vital Signs™AIRLIFECAI2025-02-17
10889483585801Vital Signs™AIRLIFECAI2025-02-17
10889483584699Vital Signs™AIRLIFECAI2025-02-11