FDA.reportPublic FDA data

Curaplex

Primary DI
00812277036459
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01457
Catalog number
8600-01457
Device description
TCCC Evacuation Skills Kit
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMRDEVICE, TRANSFER, PATIENT, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812277036459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277036459008122770364598122770364590812277036459

GMDN Terms#

Term, Definition table
TermDefinition
Portable stretcherA hand-carried device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried. It is typically used to transport a patient from areas inaccessible to conventional ambulance stretchers (e.g., mountain or marine sites, difficult indoor situations such as narrow corridors or extremely steep stairways). The patient may be strapped to the device for security.

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
05059441537298AIRPALArjohuntleigh ABFMR2026-03-23
05059441537304AIRPALArjohuntleigh ABFMR2026-03-23
05059441537311AIRPALArjohuntleigh ABFMR2026-03-23
05059441537328AIRPALArjohuntleigh ABFMR2026-03-23
05059441537335AIRPALArjohuntleigh ABFMR2026-03-23
05059441537342AIRPALArjohuntleigh ABFMR2026-03-23
00850056748360APLS Thermal WrapINTEGRATED MEDCRAFT LLCFMR2026-02-16
07333350703745Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07333350636012Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07613327681710N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.FMR2026-02-11
06975575170103YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-02-10
06975575170028YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170035YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170042YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170059YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170097YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
00199284069657Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284569546Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284790896Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970710Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970727Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970734Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970741Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970758Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970765Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970772Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970796Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268808Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268815Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMR2026-01-15