FDA.reportPublic FDA data

Curaplex

Primary DI
00812277035407
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01408
Catalog number
8600-01408
Device description
*Custom* Lucas County Igel size 5
Published
2019-08-30
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

Product Codes#

Code, Name table
CodeName
KMJLubricant, patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277035407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277035407008122770354078122770354070812277035407

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
DM exempt
false
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 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
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
E23905651Otoferm® CremeDreve Otoplastik GmbHKMJ2024-06-25
34026704921691ARROWTELEFLEX INCORPORATEDKMJ2024-04-08
30810132041762HCSConcordance Healthcare Solutions LLCKMJ2023-10-10
17290100663308Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663288Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663301Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
00304040165157Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
00304040165164Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
20326053104835Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104842Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104859Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
05030267124381OPTILUBE BOX OF 150 SACHETSIntersurgical IncorporatedKMJ2023-06-15
30810132040642HCSConcordance Healthcare Solutions LLCKMJ2023-04-07
00850047788115Oto Ease 12pk Display BoxWestone Laboratories, Inc.KMJ2023-03-02
00850047788122Oto-Ease 1/2oz bottle 1 packWestone Laboratories, Inc.KMJ2023-03-02
00850047788139Oto-Ease 1/2-oz bottles 5/pkWestone Laboratories, Inc.KMJ2023-03-02
00850047788146Oto-Ease Single Dose - 100/pkWestone Laboratories, Inc.KMJ2023-03-02
40080196291572MedlineMEDLINE INDUSTRIES, INC.KMJ2023-02-04
20326053118535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-01-13