FDA.reportPublic FDA data

Curaplex

Primary DI
00810094574581
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-5807F-SE
Catalog number
301-5807F-SE
Device description
Pediatric, Non-intubated, 7ft Oral/Nasal with Oxygen Tubing
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094574581PackageGS125In Commercial Distribution
00810094574574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094574581008100945745818100945745810810094574581
00810094574574008100945745748100945745740810094574574

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket exempt
false
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
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
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282299McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282312McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
09555866301385DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2026-04-02
10197344162550MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
10197344162567MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
09555866300869DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
10884389815311MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
10884389815069MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
10197344111107MEDLINEMEDLINE INDUSTRIES, INC.CCK2024-09-09
10841522126413TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCCK2024-07-16
10843997017685NomolineMASIMO CORPORATIONCCK2024-03-19
10620974003684Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2024-01-26
10620974003097Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003103Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003127Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003134Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003158Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003165Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003172Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003189Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003202Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003219Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003226Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003608Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003615Oxy2ProSouthmedic IncorporatedCCK2023-12-01