FDA.reportPublic FDA data

Curaplex

Primary DI
00815277020091
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
12307
Device description
Curaplex 500D Small ALS Bag, Royal Blue, w/2 Modules & Sharps Container, 18 in L x 14 in W x 11 in H
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
MMKContainer, sharps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277020091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277020091008152770200918152770200910815277020091

GMDN Terms#

Term, Definition table
TermDefinition
Medical bagA portable, durable, hand-held container of plastic, fabric, or leather designed for transportation of small medical devices, instruments, and/or supplies. It typically includes attachments for easy handling and mechanisms for closure and/or locking; it may have the internal space appropriately configured according to the intended contents (e.g., stethoscopes, sphygmomanometers, drugs). It may be dedicated for a variety of purposes and/or users, including specialization for physicians, nurses, first aid providers, or paramedics. This is a reusable 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
false
No natural rubber latex
true
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
00840456219416JMUJMU DENTAL, INCMMK2026-03-09
00840456219423JMUJMU DENTAL, INCMMK2026-03-09
00840456219430JMUJMU DENTAL, INCMMK2026-03-09
00840456219447JMUJMU DENTAL, INCMMK2026-03-09
00840456219454JMUJMU DENTAL, INCMMK2026-03-09
00840456219461JMUJMU DENTAL, INCMMK2026-03-09
10197344176595MEDLINEMEDLINE INDUSTRIES, INC.MMK2026-03-04
01850062218184VerifinePromisemed Medical Devices Inc.MMK2025-11-20
01850062218221VerifinePromisemed Medical Devices Inc.MMK2025-11-20
01850062218290VerifinePromisemed Medical Devices Inc.MMK2025-11-20
06973696790378N/ANingbo HSCC Medical Technology Co.,LtdMMK2025-11-18
00850075610020Trademark Plastics, Inc.Trademark Plastics, Inc.MMK2025-08-25
20197344139733CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139740CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
10197344139767CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139771CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139795CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00197344139814CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139825CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
20197344139849CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00197344139869CARINGMEDLINE INDUSTRIES, INC.MMK2025-08-18
00850075255047Med-Tech ResourceMed-Tech Resource, LLCMMK2025-06-04
00850075610006Trademark Plastics, Inc. Trademark Plastics, Inc.MMK2025-05-31
10810100050471KBMEDKB Medical (group), Inc.MMK2025-05-21
10810100050488KBMEDKB Medical (group), Inc.MMK2025-05-21
00810132044144HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
00810132044151HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044165HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044172HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07
10810132044189HCS SourcingConcordance Healthcare Solutions LLCMMK2025-04-07