FDA.reportPublic FDA data

easycare

Primary DI
00850015884382
Brand
easycare
Company
Synchronis Medical, LLC
Model
4518-20002
Catalog number
4518-20002
Device description
easycare Chemotherapy Spill Clean-up Kit
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWTChemotherapy Spill Clean-Up Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWTChemotherapy Spill Clean-Up KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015884382PackageGS1100In Commercial Distribution
00850015884375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015884382008500158843828500158843820850015884382
00850015884375008500158843758500158843750850015884375

GMDN Terms#

Term, Definition table
TermDefinition
Cytotoxic material spill kitA set of devices used to clean up spillage of cytotoxic material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.433.9080info@synchronismedical.com

Regulatory Flags#

DUNS number
080160207
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
true
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
00850015884641easycare3200-100003200-100002026-02-20
00850015884757easycare3200-100023200-100022026-02-20
00850015884955easycare3200-100103200-100102026-02-20
00850015884979easycare3200-100123200-100122026-02-20
00850015884993easycare3200-100143200-100142026-02-20
00850063404013easycare3200-100163200-100162026-02-20
00850063404037easycare3200-100203200-100202026-02-20
00850015884658easycare3200-100003200-100002026-02-20
00850015884764easycare3200-100023200-100022026-02-20
00850015884962easycare3200-100103200-100102026-02-20
00850015884986easycare3200-100123200-100122026-02-20
00850063404006easycare3200-100143200-100142026-02-20
00850063404020easycare3200-100163200-100162026-02-20
00850063404044easycare3200-100203200-100202026-02-20
00860000925303easycare3200-100383200-100382026-02-20
00850063404051easycare3200-100223200-100222026-02-13
00850063404075easycare3200-100243200-100242026-02-13
00850063404099easycare3200-100263200-100262026-02-13
00850063404112easycare3200-100303200-100302026-02-13
00850063404136easycare3200-100323200-100322026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008076Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-04-21
00827989008069Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-04-13
00827989007963Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-02-25
00827989007956Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-02-12
00827989007949Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2026-02-09
00850015884375easycareSynchronis Medical, LLCPWT2026-01-07
10827989004075Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2024-05-03
10827989004082Health Care Logistics, Inc®Health Care Logistics, Inc.PWT2024-05-03
10809160408452Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-09-08
20809160408459Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-09-08
10809160402962Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-06-16
20809160402969Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-06-16
10809160398944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-05-04
20809160398941Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PWT2023-05-04
10809160398609Health Care TechnologyMEDICAL ACTION INDUSTRIES INC.PWT2023-04-25
20809160398606Health Care TechnologyMEDICAL ACTION INDUSTRIES INC.PWT2023-04-25
M752HCT20570Stradis Medical, LLC.STRADIS MEDICAL, LLCPWT2017-12-07
M752HCT20575Stradis Medical, LLC.STRADIS MEDICAL, LLCPWT2017-12-07
10884389534892MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PWT2016-11-07