FDA.reportPublic FDA data

Curaplex®

Primary DI
01999720000065
Brand
Curaplex®
Company
BOUND TREE MEDICAL, LLC
Model
8600-01555
Catalog number
8600-01555
Device description
*Custom* Northwell VT BVM Kit
Published
2025-11-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01999720000072PackageGS120Not in Commercial Distribution
01999720000065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01999720000072019997200000721999720000072
01999720000065019997200000651999720000065

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Regulatory Flags#

DUNS number
070556204
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
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
00199972000153Curaplex8600-015428600-015422026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344097425MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097432MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097449MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100446MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100453MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100477MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100484MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344110902MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100460MEDLINEMEDLINE INDUSTRIES, INC.BTM2024-12-05
10195327558598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTM2023-12-21
10193489139303MedlineMEDLINE INDUSTRIES, INC.BTM2023-02-04
10193489189162MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489189179MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489181937MedlineMEDLINE INDUSTRIES, INC.BTM2022-11-10
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489003123MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-22
10193489092400MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-12
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001952MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489009767MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003116MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003758MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10190752141308AirLife™AIRLIFEBTM2021-05-03
10190752141315AirLife™AIRLIFEBTM2021-05-03
10190752141346AirLife™AIRLIFEBTM2021-05-03