FDA.reportPublic FDA data

Curaplex

Primary DI
00815277025874
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
36096
Device description
Curaplex Suction Catheter, 18 Fr, Whistle Tip and Thumb Control Port 50ea/cs
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277025874PackageGS150In Commercial Distribution
00815277025867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277025874008152770258748152770258740815277025874
00815277025867008152770258678152770258670815277025867

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal suction catheterA flexible tube typically made of plastic designed for periodic aspiration of liquids and/or semi-solids from a patient's upper airway. The tube is usually 40 to 56 cm (16 to 22 inches) in length and of small enough diameter to fit through an endotracheal (ET) tube. It usually has a smooth and rounded distal-tip configuration, including end and side holes; most include a finger-controlled valve to regulate the suctioning pressure. The device is externally attached through a large-diameter extension tube to a vacuum system and collection jar; it is used to remove excessive internal secretions from the lungs, bronchi, trachea, and pharynx. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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
00810220800157Adler Instrument CompanyAdler, Inc.JOL2026-05-26
40080196035435MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
40080196995555MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
00192896122802Frazier Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-03-10
00810130207336MSIModern Surgical Instruments LLCJOL2026-01-23
16931918174334AllesetGRI Medical & Electronic Technology Co., Ltd.JOL2026-01-21
50192253039670CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
00840343727178GEN2SURGIX MEDICAL LLCJOL2025-12-11
16974500613491Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
16974500613507Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
57613327680725Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
30889483563414BALLARD™SUNMED, LLCJOL2025-12-01
30889483564978BALLARD™SUNMED, LLCJOL2025-12-01
30889483565562BALLARD™SUNMED, LLCJOL2025-12-01
00840314238511gSourceGSOURCE LLCJOL2025-11-24
00840314238528gSourceGSOURCE LLCJOL2025-11-24
00840314238535gSourceGSOURCE LLCJOL2025-11-24
00840314238542gSourceGSOURCE LLCJOL2025-11-24
00840314238559gSourceGSOURCE LLCJOL2025-11-24
00840314238566gSourceGSOURCE LLCJOL2025-11-24
00840314238573gSourceGSOURCE LLCJOL2025-11-24
00840314238580gSourceGSOURCE LLCJOL2025-11-24
00840314238597gSourceGSOURCE LLCJOL2025-11-24
00840314238603gSourceGSOURCE LLCJOL2025-11-24
00840314238610gSourceGSOURCE LLCJOL2025-11-24
00840314238627gSourceGSOURCE LLCJOL2025-11-24
00840314238634gSourceGSOURCE LLCJOL2025-11-24
00840314238641gSourceGSOURCE LLCJOL2025-11-24
00840314238658gSourceGSOURCE LLCJOL2025-11-24
00840314238665gSourceGSOURCE LLCJOL2025-11-24