FDA.report

Curaplex

Primary DI
00810094575489
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-670253-KIT
Catalog number
301-670253-KIT
Device description
Curaplex THS Clearpath and Circuit Kit
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810094575489PackageGS120In Commercial Distribution
00810094575007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094575489008100945754898100945754890810094575489
00810094575007008100945750078100945750070810094575007

GMDN Terms

TermDefinition
In-line CPAP set, non-nebulizingA portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
070556204
Device count
1
DM exempt
true
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 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
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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

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