FDA.reportPublic FDA data

JUD care

Primary DI
26973495370003
Brand
JUD care
Company
Shenzhen Juding Medical Co., Ltd.
Model
sRoom-TC1N1B(Souc)
Published
2021-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZHApparatus, Air Handling, Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZHApparatus, Air Handling, RoomGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26973495370003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697349537000326973495370003

GMDN Terms#

Term, Definition table
TermDefinition
Patient isolation tentA mobile device designed to be erected to provide environmental isolation of a contagious patient to protect hospital personnel and other patients from exposure to non-airborne infections (e.g., diphtheria, meningococcus) whilst the patient is being treated. It includes a collapsible frame with a canopy, designed to create a small room environment for healthcare personnel to enter, and it includes an electric air filtration mechanism; the air in the chamber is filtered before it is returned to the normal external atmosphere. It may include additional features (e.g., electric door mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420584221
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973495370061JUD careDTB-012021-06-25
06973495370078JUD carePBB-012021-06-25
06973495370085JUD careLWB-012021-06-25
16973495370006JUD caresBooth- TC1B1(E), sBooth- TC1B1 (AE)2021-06-25
06973495370023JUD carePBR-012021-03-08
06973495370030JUD careDTR-012021-03-08
06973495370047JUD careLWR-012021-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852348007155AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007179AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007186AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007193AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007308IlluviaAEROBIOTIX USA LLCFZH2023-06-02
00852348007988IlluviaAEROBIOTIX USA LLCFZH2023-03-01
00852348007322IlluviaAEROBIOTIX USA LLCFZH2021-12-03
00852348007896IlluviaAEROBIOTIX USA LLCFZH2021-12-03
00852348007292IlluviaAEROBIOTIX USA LLCFZH2021-09-01
00852348007889IlluviaAEROBIOTIX USA LLCFZH2021-09-01
00841132124277ACLORTHOPEDIATRICS CORP.FZH2021-07-06
06973495370061JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370078JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370085JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
16973495370006JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370023JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
06973495370030JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
06973495370047JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
00852348007117IlluviaAEROBIOTIX USA LLCFZH2019-02-14
00852348007223IlluviaAEROBIOTIX USA LLCFZH2019-02-14
00852348007995IlluviaAEROBIOTIX USA LLCFZH2019-02-14