FDA.reportPublic FDA data

Curaplex

Primary DI
00815277025447
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-181EA
Device description
Curaplex Oxygen Mask, Adult, Elongated, High Conc, Partial NRB, Metal Noseclip, Reservoir Bag 50ea/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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMASK, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277025454PackageGS150In Commercial Distribution
00815277025447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277025454008152770254548152770254540815277025454
00815277025447008152770254478152770254470815277025447

GMDN Terms#

Term, Definition table
TermDefinition
Foetal scalp electrode, spiralA sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a spiralled (either single- or double-helix) metallic electrode with a sharp tip that is directly inserted into the foetal scalp with a screwing action; and an adaptor cable that may include a transducer. The electrode penetrates into the scalp up to 2.5 mm (0.1 inch); it is usually inserted with a dedicated applicator that may be included. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199972000801Curaplex670293-KIT670293-KIT2026-09-30
00199972000825Curaplex670294-KIT2026-09-30
00199972000849Curaplex670295-KIT670295-KIT2026-09-30
00199972000863Curaplex670296-KIT670296-KIT2026-09-30
00199972000887Curaplex670297-KIT670297-KIT2026-09-30
00199972000900Curaplex670298-KIT670298-KIT2026-09-30
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00812277031010Curaplex1110-140061110-140062018-12-15
00812277031027Curaplex1110-140071110-140072018-12-15
00812277031034Curaplex1110-140081110-140082018-12-15
00812277031041Curaplex1110-140091110-140092018-12-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118621137Endure IndustriesENDURE INDUSTRIESBYG2026-08-17
00840118621144Endure IndustriesENDURE INDUSTRIESBYG2026-08-14
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04719874950972Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951153Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951160Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951177Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951184Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955793Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955809Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955816Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956264Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956271Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956288Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956295Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956301Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956318Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
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00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABSBYG2026-06-10
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
00848530108717Nasal CPAP MaskSunset Healthcare Solutions, Inc.BYG2026-04-07
00848530108724Nasal CPAP MaskSunset Healthcare Solutions, Inc.BYG2026-04-07