FDA.reportPublic FDA data

Curaplex

Primary DI
00812277035384
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01406
Catalog number
8600-01406
Device description
*Custom* Lucas County Igel size 3
Published
2019-08-30
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
CAOAIRWAY, ESOPHAGEAL (OBTURATOR)
JOLCATHETER AND TIP, SUCTION
KMJLubricant, patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAOAirway, Esophageal (Obturator)Anesthesiology2
JOLCatheter And Tip, SuctionGeneral Hospital2
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094573249PackageGS140In Commercial Distribution
00812277035384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094573249008100945732498100945732490810094573249
00812277035384008122770353848122770353840812277035384

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, single-useA curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. 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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199972000504Curaplex8600-015668600-015662026-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800492Adler Instrument CompanyAdler, Inc.JOL2026-07-17
00846159040678SCANLAN® Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17
10888277407954MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-07-17
04719874957568Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
04719874958503Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
00190776396794MillenniumAvalign Technologies, Inc.JOL2026-07-14
00888937033823ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033830ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033847ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033854ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033861ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00692379000097Water-based Lubricant for UrestaResilia IncKMJ2026-07-03
00848530109110Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.JOL2026-06-10
10192253038927ArgyleCardinal Health 200, LLCJOL2026-05-07
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
10080196994137MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-27
10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03