FDA.reportPublic FDA data

EMSRUN

Primary DI
06974567742267
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
CR-03
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974567742267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974567742267069745677422676974567742267

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck immobilizer, single-useA rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542972552
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974567745800EMSRUNPZQJ00022023-05-29
06974567741116EMSRUNPZJE00022022-12-02
06974567741147EMSRUNPZSI00082022-12-02
06974567742632EMSRUNPZSI00062022-12-02
06974567742649EMSRUNPZQJ00012022-12-02
06974567740515EMSRUNWSX-H2022-12-06
06974567745411Lightning X Products,IncLXCP1002022-12-07
06974567742717EMSRUNPZBA00012022-12-02
06974567742724EMSRUNPZBA00122022-12-02
86974567746698RHINO RESCUEPZJJ00072023-10-10
86974567746926RHINO RESCUEPZJJ00072023-06-12
9697456774669566974567746694PZJJ00072023-10-10
96974567746923RHINO RESCUEPZJJ00072023-06-12
06974567749631Rhino RescuePZJJ00012022-12-08
06974567746692RHINO RESCUEPZJJ00072024-08-08
06974567746920RHINO RESCUEPZJJ00072024-08-08
06974567747989RHINO RESCUEPZJJ00072023-03-14
16974567747986RHINO RESCUEPZJJ00072023-03-14
06974567745428Lightning X Products,IncLXEFB2022-12-07
06974567740713EMSRUNPZJJ00142022-12-05

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Primary DI, Brand, Company table
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00650551006824ILSO™PMT CORPORATIONMRI2026-07-17
00650551006831ILSO™PMT CORPORATIONMRI2026-07-17
00650551006848ILSO™PMT CORPORATIONMRI2026-07-17
00650551006855ILSO™PMT CORPORATIONMRI2026-07-17
00650551006862ILSO™PMT CORPORATIONMRI2026-07-17
00650551006879ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006886ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006893ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006909ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006916ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006923ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006930ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006947ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006954ILSO™PMT CORPORATIONMRI2026-07-17
00650551006961ITLSO™PMT CORPORATIONMRI2026-07-17
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00645517897776TrulifeTRULIFE LIMITEDMRI2025-08-25
04719879646108ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646115ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10