FDA.reportPublic FDA data

Curaplex

Primary DI
00815277022309
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01126
Catalog number
8600-01126
Device description
Custom PHI Vent - Adult Kit
Published
2016-12-14
Public version status
Update
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
CAHFilter, bacterial, breathing-circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094572112PackageGS120In Commercial Distribution
00815277022309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094572112008100945721128100945721120810094572112
00815277022309008152770223098152770223090815277022309

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
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
01999720000065Curaplex®8600-015558600-015552025-11-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
30889483228108Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228115Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228122Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228139Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228146Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228153Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228160Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228177Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228207Cardinal HealthSUNMED, LLCCAH2025-12-31
20889483229740BlockAide™SUNMED, LLCCAH2025-12-31
20889483231675Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233198Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233891Vital Signs™SUNMED, LLCCAH2025-12-31
20889483231750PRO-NOX™SUNMED, LLCCAH2025-12-30
20889483232306Vital Signs™SUNMED, LLCCAH2025-12-30
20889483232849Vital Signs™SUNMED, LLCCAH2025-12-30
20889483233389Vital Signs™SUNMED, LLCCAH2025-12-30
20889483234195Vital Signs™SUNMED, LLCCAH2025-12-30
20889483221188Vital Signs™SUNMED, LLCCAH2025-12-23
20889483222543Vital Signs™SUNMED, LLCCAH2025-12-23
20889483226787Vital Signs™SUNMED, LLCCAH2025-12-23
20889483230487Vital Signs™SUNMED, LLCCAH2025-12-23
20889483231163Vital Signs™SUNMED, LLCCAH2025-12-23