FDA.reportPublic FDA data

easycare

Primary DI
00850063404365
Brand
easycare
Company
Synchronis Medical, LLC
Model
3000-10002
Catalog number
3000-10002
Device description
Child Full Arm 6-7 yrs Waterproof Protector
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIACover, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIACover, CastGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063404365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063404365008500634043658500634043650850063404365

GMDN Terms#

Term, Definition table
TermDefinition
Cast/bandage waterproof bathing cover, reusableA device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.433.9080info@synchronismedical.com

Regulatory Flags#

DUNS number
080160207
Device count
1
Premarket exempt
true
No natural rubber latex
true

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
00810178889976ViveVIVE HEALTH LLCKIA2026-06-03
00810178889983ViveVIVE HEALTH LLCKIA2026-06-03
00810178889990ViveVIVE HEALTH LLCKIA2026-06-03
00810226440005ViveVIVE HEALTH LLCKIA2026-06-03
00810226440012ViveVIVE HEALTH LLCKIA2026-06-03
00810226440029ViveVIVE HEALTH LLCKIA2026-06-03
06973641880017Medi GradeChengdu Cryo-push Medical Technology Co.,Ltd.KIA2026-02-25
00850063404198easycareSynchronis Medical, LLCKIA2026-01-29
00850063404204easycareSynchronis Medical, LLCKIA2026-01-29
00850063404211easycareSynchronis Medical, LLCKIA2026-01-29
00850063404228easycareSynchronis Medical, LLCKIA2026-01-29
00850063404235easycareSynchronis Medical, LLCKIA2026-01-29
00850063404242easycareSynchronis Medical, LLCKIA2026-01-29
00850063404259easycareSynchronis Medical, LLCKIA2026-01-29
00850063404266easycareSynchronis Medical, LLCKIA2026-01-29
00850063404273easycareSynchronis Medical, LLCKIA2026-01-29
00850063404280easycareSynchronis Medical, LLCKIA2026-01-29
00850063404358easycareSynchronis Medical, LLCKIA2026-01-29
00850063404297easycareSynchronis Medical, LLCKIA2026-01-23
00850063404303easycareSynchronis Medical, LLCKIA2026-01-23
00850063404310easycareSynchronis Medical, LLCKIA2026-01-23
00850063404327easycareSynchronis Medical, LLCKIA2026-01-23
00850063404334easycareSynchronis Medical, LLCKIA2026-01-23
00850063404341easycareSynchronis Medical, LLCKIA2026-01-23
10618125192318AquaGuardTIDI PRODUCTS, LLCKIA2025-09-23
06978521200008noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200015noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200022noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200039noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200046noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11