FDA.reportPublic FDA data

Protective Vest No Sleeve

Primary DI
M1435040060
Brand
Protective Vest No Sleeve
Company
Kenad SG Medical, Inc.
Model
Protective Vest No Sleeve Large
Catalog number
50-4006
Device description
The Vest Holder is intended to be used to limit the movement of the patient's body.
Published
2023-09-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M1435040060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-345-0606sales@kenad.com

Regulatory Flags#

DUNS number
626997381
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M1435040070Protective Vest No SleeveProtective Vest No Sleeve Xlarge50-40072023-09-17
M143501500L1Universal Blue Limb HolderUniversal Blue Limb Holder 30in Tail50-1500L2023-09-17
M14350180043Universal Blue Limb HolderLimb Holder W/Quick Adjust at Wrist50-18002023-09-17
M1435034000Universal Waist HolderUniversal Waist Holder Pediatric50-34002023-09-17
M1435040030Protective Vest No SleeveProtective Vest No Sleeve Xsmall50-40032023-09-17
M1435040040Protective Vest No SleeveProtective Vest No Sleeve Small50-40042023-09-17
M1435040050Protective Vest No SleeveProtective Vest No Sleeve Medium50-40052023-09-17
M14350370000Universal 12IN Waist Holder AdultPatient Protective Waist Holder Adult50-37002023-08-06
M1435041030Protective Mesh Vest No SleevePatient Protective Vest Mesh Without Sleeves Xsmal50-41032023-08-06
M1435041040Protective Mesh Vest No Sleeve Patient Protective Vest Mesh without Sleeves Small50-41042023-08-06
M1435041050Protective Mesh Vest No SleevePatient Protective Vest Mesh Without Sleeves Mediu50-41052023-08-06
M14350410601Protective Mesh Vest No SleevePatient Protective Vest Mesh Without Sleeves Large50-41062023-08-06
M14350410702Protective Mesh Vest No SleevePatient Protective Vest Mesh Without Sleeves XLarg50-41072023-08-06
M14350410803Protective Mesh Vest No SleevePatient Protective Vest Mesh Without Sleeves XXLar50-41082023-08-06
M1435035000Universal Waist HolderPatient Protective Waist Holder Adult50-35002023-06-27
M1435036000Universal Waist HolderPatient Protective Waist Holder w/slit50-36002023-06-27
M1435010001Protective MittProtective Mitt without Stay's Adult50-10002023-06-25
M1435010101Protective MittPatient Protective Mitt Child w/o Stays50-10102023-06-25
M1435010201Protective MittPatient Protective Mitt Infant w/o Stays50-10202023-06-25
M1435011101Protective MittProtective Mitt with Stay Child50-11102023-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
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10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
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10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
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