FDA.reportPublic FDA data

Curaplex

Primary DI
00815277025409
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
30078
Device description
Curaplex Select PEEP Valve, 5-20cm H2O, 22mm OD, Disposable 200ea/cs
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYEAttachment, breathing, positive end expiratory pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053466000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053466000HSINER RESUSCITATORHsiner Co., Ltd.2006-03-22BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277025416PackageGS1200In Commercial Distribution
00815277025409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277025416008152770254168152770254160815277025416
00815277025409008152770254098152770254090815277025409

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference20Millimeter

Regulatory Flags#

DUNS number
070556204
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00810094578534Curaplex®BOUND TREE MEDICAL, LLCBYE2025-08-06
00810094578008Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578015Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578022Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578039Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578046Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00026072001479EMAllied Medical, LLCBYE2024-05-28
00810094574987CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094575007CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094574994CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094575014CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
10884521831643ShileyCovidien LPBYE2023-02-18
10884521831636ShileyCovidien LPBYE2023-02-16
00810071637261CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
00810071637278CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
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08498840012130VYGONVygon CorporationBYE2020-03-12
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15019315061073PortexICU MEDICAL, INC.BYE2020-03-12
15019315061080PortexICU MEDICAL, INC.BYE2020-03-12
10190752133181AirLife™AIRLIFEBYE2020-01-15