FDA.reportPublic FDA data

Curaplex

Primary DI
00815277020893
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
36613
Device description
Curaplex I/O Kit, w/15 Ga Jamshidi Needle
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
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071638985PackageGS120In Commercial Distribution
00815277020893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071638985008100716389858100716389850810071638985
00815277020893008152770208938152770208930815277020893

GMDN Terms#

Term, Definition table
TermDefinition
Intraosseous infusion kitA collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. 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
false
Donation ID number
false
Contains natural rubber latex
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506757Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
00810126506764Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
18699207302025Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207305033Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207310037Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207311003Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207320029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207350026Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
04046955850839Omnifix®B. BRAUN MEDICAL INC.FMF2026-03-08
18800109007035DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007073DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007127DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
00849296013345WelmedWELMED INC.FMF2026-02-15
00849296013352WelmedWELMED INC.FMF2026-02-15
00849296013369WelmedWELMED INC.FMF2026-02-15
00849296013376WelmedWELMED INC.FMF2026-02-15
00849296013383WelmedWELMED INC.FMF2026-02-15
00849296013390WelmedWELMED INC.FMF2026-02-15
00849296013406WelmedWELMED INC.FMF2026-02-15
00849296013413WelmedWELMED INC.FMF2026-02-15
00849296013420WelmedWELMED INC.FMF2026-02-15
00849296013437WelmedWELMED INC.FMF2026-02-15
00849296013444WelmedWELMED INC.FMF2026-02-15
00849296013451WelmedWELMED INC.FMF2026-02-15
00849296013468WelmedWELMED INC.FMF2026-02-15
00849296013475WelmedWELMED INC.FMF2026-02-15
00849296013482WelmedWELMED INC.FMF2026-02-15
00849296013499WelmedWELMED INC.FMF2026-02-15
00849296013505WelmedWELMED INC.FMF2026-02-15
20850083784007Comfort EZS.D.I. USA, INC.FMF2026-02-13