FDA.report

Curaplex

Primary DI
00817617023373
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-100EA
Catalog number
301-100EA
Device description
Nasal Cannula, Flared-Tip, Adult,
Published
2017-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CATCANNULA, NASAL, OXYGEN

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817617023373PackageGS150In Commercial Distribution
00817617022895PrimaryGS10

GMDN Terms

TermDefinition
Basic nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
070556204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
true
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
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 DIBrandCompanyProduct codePublished
20197344155122MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
20885632467384HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467391HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467445HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467452HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
15694311111894Nox Nasal Pressure Cannula with FilterNox Medical ehf.CAT2026-01-28
00850077887017AERIS Airway - MSA Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887048AERIS Airway - Male Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887079AERIS Airway - Female Luer KitAirway Innovations, Inc.CAT2026-01-08
20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
20197344162694CARINGMEDLINE INDUSTRIES, INC.CAT2025-11-27
20197344158406HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158413HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158420HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158437HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158444HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158451HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULTIntersurgical IncorporatedCAT2025-09-23
20197344158468HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161161MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161178MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161185MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161192MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161208MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161215MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161222MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161239MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344155061MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21