FDA.reportPublic FDA data

none

Primary DI
06978521200060
Brand
none
Company
Ningbo Huirui Technology Co., Ltd.
Model
E-L
Published
2025-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06978521200060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978521200060069785212000606978521200060

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

Regulatory Flags#

DUNS number
979750504
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978521200008noneA-S2025-04-11
06978521200015noneA-M2025-04-11
06978521200022noneA-L2025-04-11
06978521200039noneA-XL2025-04-11
06978521200046noneE-S2025-04-11
06978521200053noneE-M2025-04-11
06978521200077noneE-XL2025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850063404365easycareSynchronis 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
06978521200053noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
06978521200077noneNingbo Huirui Technology Co., Ltd.KIA2025-04-11
00057475260941BIOS LivingThermor LtdKIA2024-08-19
00057475260958BIOS LivingThermor LtdKIA2024-08-19
00057475260972BIOS LivingThermor LtdKIA2024-08-19