FDA.reportPublic FDA data

Curaplex

Primary DI
00812277036237
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
670186-KIT
Catalog number
670186-KIT
Device description
*THS ONLY* Heated Bi-PAP Setup Kit
Published
2020-04-30
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
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094571245PackageGS120In Commercial Distribution
00812277036237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094571245008100945712458100945712450810094571245
00812277036237008122770362378122770362370812277036237

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE Intersurgical IncorporatedBZE2025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6MIntersurgical IncorporatedBZE2025-04-16
30889483572126AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573383AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573802AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483605480AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616932AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616956AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
0503026703366922MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709791322MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703368322MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709637422MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703367622MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6MIntersurgical IncorporatedBZE2025-03-14
0503026716192822MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
30889483584105AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483588356AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483595842AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483615618AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
10889483616963AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483586529AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587137AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587328AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483591288AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483572652AirLife™Sunmed Group Holdings, LLCBZE2025-03-05
30889483572904AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483616994AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483617007AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
30889483581043AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581081AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581135AirLife™Sunmed Group Holdings, LLCBZE2025-02-21