FDA.reportPublic FDA data

Curaplex

Primary DI
00812277037470
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
36276
Catalog number
36276
Device description
Curaplex Mask, Air Cushioned, Toddler, Size 2, Yellow 50ea/cs
Published
2022-12-30
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
BYGMASK, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277038774PackageGS150In Commercial Distribution
00812277037470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277038774008122770387748122770387740812277038774
00812277037470008122770374708122770374700812277037470

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, single-useA non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
true
Premarket 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
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
00840118621137Endure IndustriesENDURE INDUSTRIESBYG2026-08-17
00840118621144Endure IndustriesENDURE INDUSTRIESBYG2026-08-14
04719874950675Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
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
00607411919039Salter Labs® High Concentration partial rebreatherSALTER LABSBYG2026-06-10
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