FDA.reportPublic FDA data

Protective Mesh Vest No Sleeve

Primary DI
M14350410702
Brand
Protective Mesh Vest No Sleeve
Company
Kenad SG Medical, Inc.
Model
Patient Protective Vest Mesh Without Sleeves XLarg
Catalog number
50-4107
Published
2023-08-06
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
M14350410702PrimaryHIBCC0

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
M1435040060Protective Vest No SleeveProtective Vest No Sleeve Large50-40062023-09-17
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
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
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
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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
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
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10190676002518POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002525POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002532POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002549POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
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10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
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