FDA.reportPublic FDA data

Curaplex

Primary DI
00818834028448
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-PrO2LT
Catalog number
301-PrO2LT
Device description
MASK,PrO2,OX,ADL,HI.CONC,ETCO2,M2M,30/BX
Published
2024-01-10
Public version status
New
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
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
00818834028523PackageGS130In Commercial Distribution
00818834028448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818834028523008188340285238188340285230818834028523
00818834028448008188340284488188340284480818834028448

GMDN Terms#

Term, Definition table
TermDefinition
Capnography oxygen maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway, and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. It includes exhaled air sampling tubing for connection to a carbon dioxide monitor (capnograph), or physiology-monitoring sedation/anaesthesia system, for the measurement of end-tidal carbon dioxide (EtCO2) in expiratory gases; it is typically used during anaesthesia/sedation or bedside monitoring. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
010712461
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818834028417Curaplex301-0903301-09032020-11-30
00818834028837MiiS Horus Endoscope Display System -Video BoxEVS 7002025-08-12
00812574026481Curaplex301-P3002EA2017-02-06
00818834028608Curaplex301-12218301-122182024-03-10
00818834028615Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028622Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028639Curaplex301-12218301-122182024-03-10
00818834028646Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028684Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028455Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2024-01-10
00818834028462Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2024-01-10
00818834028479Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2024-01-10
00818834028486Curaplex301-PrO2LTEZ301-PrO2LTEZ2024-01-10
00818834028493Curaplex301-PrO2LT-FM301-PrO2LT-FM2024-01-10
00818834028509Curaplex301-PrO2LT-0301-PrO2LT-02024-01-10
00818834028516Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2024-01-10
00812574026221Curaplex301-005-100102017-02-06
00812574025064Curaplex301-005-100102017-12-22
00818834020466Curaplex301-180U301-180U2019-02-10
00818834020473Curaplex301-181U301-181U2019-02-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
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